[{"additionalPlain":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.\n \nWho we are\n \nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.\n \nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.\n \nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.\n \nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.\n \nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.\n \nNotice to staffing firms\n \nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.\n","additional":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
\n
\nWho we are
\n
\nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\nNotice to staffing firms
\n
\nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
","categories":{"commitment":"Regular, Full-Time Employee","department":"General & Administrative","location":"Menlo Park, CA","team":"Finance","allLocations":["Menlo Park, CA"]},"createdAt":1776445466100,"descriptionPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n","description":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\n
Position Summary: Reporting into our CFO & Head of Strategy, the (Senior) Director, FP&A (depending on experience) will lead financial planning, forecasting, and reporting at Orca Bio, building upon our existing FP&A processes to scale into a commercial-ready function. This individual will serve as the functional leader for FP&A and is a highly visible, hands-on leader responsible for evolving our structure, processes, and financial rigor in a fast-growing, pre-commercial biotech environment. The role partners closely with Clinical Development, R&D, Manufacturing Operations, Medical Affairs, and Commercial leadership to drive budgeting, forecasting, and decision support across the organization.
\n
This position will focus on core FP&A responsibilities (budgeting, forecasting, and operational finance), while partnering with leadership and adjacent functions on longer-term strategic and valuation-related initiatives.
\n
\n\n
Own company-wide budgeting, forecasting, and monthly/quarterly actuals analysis, including variance analysis vs. plan\nOwn the company’s financial forecast and ensure accuracy, consistency, and alignment across functions\nEnhance existing FP&A processes, reporting cadence, and financial infrastructure to support commercial launch\nLead financial planning across R&D, Clinical, Manufacturing, and Commercial functions\nOwn commercial financial planning, including revenue forecasts, patient flow models, and demand assumptions, in close partnership with Commercial leadership\nPartner with Accounting to align on cost visibility, including manufacturing economics and COGS drivers\nDevelop long-range financial models to support strategic planning, investment decisions, and Board-level discussions\nPartner with functional leaders to track performance against plan and drive accountability for financial targets\nTranslate financial results into clear, actionable insights for executive leadership\n\n"},{"text":"Qualifications","content":"\n\n
Bachelor’s degree in Finance, Accounting, Economics, or related field (MBA preferred)\n12+ years of progressive FP&A experience, including leadership experience in a biotech or life sciences company, preferably with commercial launch experience\nDemonstrated experience building or scaling FP&A processes in a high-growth, small to mid-sized organization\nExperience partnering with commercial organizations, including revenue forecasting and launch planning\nExperience supporting clinical organizations, including clinical development forecasting and portfolio planning\nFamiliarity with manufacturing environments; in-house manufacturing experience preferred\nAdvanced financial modeling and analytical skills, with ability to translate data into business insights\nPrior experience in smaller or mid-sized biotech environments preferred; candidates should be comfortable operating with limited structure and high ownership\n\n"}],"salaryRange":{"min":210000,"max":260000,"currency":"USD","interval":"per-year-salary"},"text":"(Senior) Director, FP&A","country":"US","workplaceType":"onsite","opening":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n
Position Summary: Reporting into our CFO & Head of Strategy, the (Senior) Director, FP&A (depending on experience) will lead financial planning, forecasting, and reporting at Orca Bio, building upon our existing FP&A processes to scale into a commercial-ready function. This individual will serve as the functional leader for FP&A and is a highly visible, hands-on leader responsible for evolving our structure, processes, and financial rigor in a fast-growing, pre-commercial biotech environment. The role partners closely with Clinical Development, R&D, Manufacturing Operations, Medical Affairs, and Commercial leadership to drive budgeting, forecasting, and decision support across the organization.
\n
This position will focus on core FP&A responsibilities (budgeting, forecasting, and operational finance), while partnering with leadership and adjacent functions on longer-term strategic and valuation-related initiatives.
\n
The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
\n
\nWho we are
\n
\nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\nNotice to staffing firms
\n
\nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
","categories":{"commitment":"Regular, Full-Time Employee","department":"Commercial","location":"Remote","team":"Marketing","allLocations":["Remote"]},"createdAt":1767902054479,"descriptionPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n\n\nSummary: The Associate Director, Market Development, West is a senior field-based position within the US commercial organization focused on commercial Key Opinion Leader (KOL) relationship engagement, market insight generation to inform marketing strategy, brand and disease awareness messaging, promotional speaker training and development, and key Center of Excellence (COE) profiling. Reporting to the Head of Marketing and New Product Planning, the Market Development team is a field-based extension of the Marketing team and will work closely with field Sales, Medical Affairs, and other cross-functional members of the Commercial team. They will be instrumental in facilitating COE onboarding prior to and during the Commercial launch of Orca-T, creating Brand strategy, and developing Brand tactics. \n \n","description":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
Summary: The Associate Director, Market Development, West is a senior field-based position within the US commercial organization focused on commercial Key Opinion Leader (KOL) relationship engagement, market insight generation to inform marketing strategy, brand and disease awareness messaging, promotional speaker training and development, and key Center of Excellence (COE) profiling. Reporting to the Head of Marketing and New Product Planning, the Market Development team is a field-based extension of the Marketing team and will work closely with field Sales, Medical Affairs, and other cross-functional members of the Commercial team. They will be instrumental in facilitating COE onboarding prior to and during the Commercial launch of Orca-T, creating Brand strategy, and developing Brand tactics.
\n
","id":"45d6c8dc-9c4a-4544-9584-05250656b40b","lists":[{"text":"Essential Duties & Key Responsibilities","content":"\nKOL Development\nDesign and execute KOL engagement strategy, including relationship development, message alignment and evaluation, scientific and product feedback, and targeted marketing initiatives\nAssume HCP-facing responsibility for the Marketing team in influencing KOL understanding of unmet need in alloHSCT, obtain and synthesize messaging feedback, and implement positioning and messaging adjustments\nManage Commercial KOL engagement planning and execution at major congresses\n\n
\n\nBrand Strategy and Regional Marketing \nLeverage KOL insights to inform Brand strategy, positioning, and messaging during the Brand Building process\nRegional congress strategy and execution, KOL engagement, exhibit staffing, strategic sponsorship management, Brand Plan insight and support, advisory board content and execution.\nManagement of regional marketing budget\n\n
\n\nPromotional Physician Speaker Bureau \nIdentification, recruitment, and coaching of KOL speakers\nVendor selection and management\nContent creation and PRC approval\nBureau management and program execution\n\n
\n\nCommercial COE Profiling and Insights \nIdentify KOL champions and lead KOL-specific scientific education and clinical alignment\nContribute to cross-functional pre-onboarding, multi-domain profiling of select ATCs\n\n
\n\nInternal Collaboration to Optimize Launch Readiness and Execution\nIntegration and strategic planning with regional cross-functional team, including Market Access, Medical Affairs, and Commercial Operations\nInteraction with all levels of the Sales Force to ensure effective communication, alignment, prioritization and implementation of Brand tactics\nComply with all laws, regulations and policies that govern the conduct of Orca Bio activities\n"},{"text":"Minimum Qualifications","content":"\nExtensive experience in hematology/oncology and allogeneic bone marrow transplant sales or marketing; field-based marketing experience preferred\nLeukemia and/or bone marrow transplant clinical fluency\nAcademic center account experience\nLaunch experience\nDemonstrated ability to work cross functionally with other teams\n10+ years of related experience with a BA/BS degree in a related discipline, advanced degree preferred (MA/MBA/PharmD)\nAbility to travel ~50% of the time (will include overnight travel)\n"},{"text":"Preferred Qualifications","content":"\nExperience working in-house at a small or mid-sized biotechnology company\nExperience at a company progressing from clinical stage through commercialization\nCell therapy or immune-oncology experience\n"}],"text":"Associate Director, Market Development - Mid-West","country":"US","workplaceType":"remote","opening":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.Summary: The Associate Director, Market Development, West is a senior field-based position within the US commercial organization focused on commercial Key Opinion Leader (KOL) relationship engagement, market insight generation to inform marketing strategy, brand and disease awareness messaging, promotional speaker training and development, and key Center of Excellence (COE) profiling. Reporting to the Head of Marketing and New Product Planning, the Market Development team is a field-based extension of the Marketing team and will work closely with field Sales, Medical Affairs, and other cross-functional members of the Commercial team. They will be instrumental in facilitating COE onboarding prior to and during the Commercial launch of Orca-T, creating Brand strategy, and developing Brand tactics.
\n
","descriptionBodyPlain":"Summary: The Associate Director, Market Development, West is a senior field-based position within the US commercial organization focused on commercial Key Opinion Leader (KOL) relationship engagement, market insight generation to inform marketing strategy, brand and disease awareness messaging, promotional speaker training and development, and key Center of Excellence (COE) profiling. Reporting to the Head of Marketing and New Product Planning, the Market Development team is a field-based extension of the Marketing team and will work closely with field Sales, Medical Affairs, and other cross-functional members of the Commercial team. They will be instrumental in facilitating COE onboarding prior to and during the Commercial launch of Orca-T, creating Brand strategy, and developing Brand tactics. \n \n","hostedUrl":"https://jobs.lever.co/orcabiosystems/45d6c8dc-9c4a-4544-9584-05250656b40b","applyUrl":"https://jobs.lever.co/orcabiosystems/45d6c8dc-9c4a-4544-9584-05250656b40b/apply"},{"additionalPlain":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.\n \nWho we are\n \nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.\n \nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.\n \nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.\n \nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.\n \nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.\n \nNotice to staffing firms\n \nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.\n","additional":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
\n
\nWho we are
\n
\nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\nNotice to staffing firms
\n
\nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
","categories":{"commitment":"Regular, Full-Time Employee","department":"Manufacturing","location":"Sacramento, CA","team":"Planning, Materials & Procurement","allLocations":["Sacramento, CA"]},"createdAt":1765989864296,"descriptionPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n \nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.\n\n\nThe Associate Director, Production Planning & Procurement leads planning and procurement functions while driving the design, implementation and optimization of manufacturing execution systems (MES) and enterprise resource planning connections across cell therapy manufacturing sites. This role ensures robust, compliant and scalable planning and procurement processes with digital systems to enable accurate, real-time visibility and uninterrupted production of clinical and commercial cell therapy products. The Associate Director will partner with Manufacturing, Finance IT, Facilities and Quality to deliver a reliable planning foundation that supports operations and data-drive decision-making. \n","description":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
The Associate Director, Production Planning & Procurement leads planning and procurement functions while driving the design, implementation and optimization of manufacturing execution systems (MES) and enterprise resource planning connections across cell therapy manufacturing sites. This role ensures robust, compliant and scalable planning and procurement processes with digital systems to enable accurate, real-time visibility and uninterrupted production of clinical and commercial cell therapy products. The Associate Director will partner with Manufacturing, Finance IT, Facilities and Quality to deliver a reliable planning foundation that supports operations and data-drive decision-making.
","id":"4f078d1e-aeaa-4ab3-adf2-143799eb6223","lists":[{"text":"Physical Demands","content":"\nProduction Associate Roles: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.\nMost roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.\n"},{"text":"Work Conditions","content":"\nMany roles must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video-based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs.\n"},{"text":"Key Responsibilities","content":"\n \n\nProduction Planning
\n\nLead site production planning, production scheduling, and material planning to meet customer service and operational targets\nManage production and material capacity planning aligned with clinical and commercial demand forecasts developing and analyzing operational scenarios to support capacity and demand needs.\nEnsure effective inventory strategies to maintain optimal raw material, consumable, and finished product levels.\nDevelop Sales & Operations Planning (S&OP) processes for cell therapy programs across internal manufacturing sites.\nFacilitate relationships with internal commercial stakeholders and suppliers and vendors, where appropriate\n\n
\nDigital Systems
\n\nServe as site business lead for MES and ERP system deployment, configuration, and optimization.\nPartner with IT, Engineering, and other functions to define requirements, ensure seamless integration, and enable end-to-end planning functionality.\nTranslate planning processes into digital workflows, ensuring master data accuracy, transactional discipline, and real-time visibility.\nDrive user adoption, training, and change management for MES/ERP solutions at the site.\n\n
\nProcess Improvement & Analytics
\n\nImplement best practices in production planning, leveraging system capabilities to improve forecast accuracy, scheduling efficiency, material availability, and cost competitiveness.\nEstablish KPIs and dashboards for planning performance, leveraging ERP/MES data for decision-making.\nIdentify and resolve systemic bottlenecks in planning processes through digital solutions\nTeam Leadership & Development\nLead, coach and develop a team of planners and system users.\nBuild a culture of digital fluency, continuous improvement and data-driven decision-making within the planning function. Build a culture of digital fluency, continuous improvement, and data-driven decision-making within the planning function.\n\n
\nLeadership
\n\nEffectively lead, mentor, and coach a direct team\nOversees the daily workflow of the department and performance to goals and deliverables\nRecruits, interviews, hires, and trains new staff \nProvides constructive and timely performance feedback and evaluations \n\n
"},{"text":"Minimum Qualifications","content":"\nBachelor’s degree in Supply Chain, Engineering, Life Sciences, or related fields.\n5-7 years of progressive supply chain experience in biomanufacturing, cell therapies or advanced therapies.\nLeadership of digital transformation initiatives including MES and ERP systems.\nStrong knowledge of production planning, material requirements planning (MRP), and capacity planning within manufacturing.\nProven success leading cross-functional teams and driving operational results.\nExcellent interpersonal, leadership, and communication skills.\n"},{"text":"Preferred Qualifications","content":"\nExperience with autologous or allogeneic cell therapy supply chains.\nFamiliarity with both clinical and commercial supply chain models.\nKnowledge of manufacturing, chain of identity/custody requirements, and vein-to-vein workflows.\n"},{"text":"Personal Qualities & Physical Demands","content":"\nDemonstrates strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment \nStrong interpersonal skills and ability to communicate effectively \nAbility to work in a collaborative manner \nStrong problem-solving skills \nDomestic and international travel may be required from time to time as needed (approximately 10-25%). Office and GMP warehouse/manufacturing environment. \nMay require occasional lifting up to 25 lbs. and gowning into cleanroom areas. \nRequires sitting, standing, working in an office environment and computer use.\n"}],"salaryRange":{"min":145000,"max":175000,"currency":"USD","interval":"per-year-salary"},"text":"Associate Director, Production Planning & Procurement","country":"US","workplaceType":"onsite","opening":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
","openingPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n \nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.\n","descriptionBody":"The Associate Director, Production Planning & Procurement leads planning and procurement functions while driving the design, implementation and optimization of manufacturing execution systems (MES) and enterprise resource planning connections across cell therapy manufacturing sites. This role ensures robust, compliant and scalable planning and procurement processes with digital systems to enable accurate, real-time visibility and uninterrupted production of clinical and commercial cell therapy products. The Associate Director will partner with Manufacturing, Finance IT, Facilities and Quality to deliver a reliable planning foundation that supports operations and data-drive decision-making.
","descriptionBodyPlain":"The Associate Director, Production Planning & Procurement leads planning and procurement functions while driving the design, implementation and optimization of manufacturing execution systems (MES) and enterprise resource planning connections across cell therapy manufacturing sites. This role ensures robust, compliant and scalable planning and procurement processes with digital systems to enable accurate, real-time visibility and uninterrupted production of clinical and commercial cell therapy products. The Associate Director will partner with Manufacturing, Finance IT, Facilities and Quality to deliver a reliable planning foundation that supports operations and data-drive decision-making. \n","hostedUrl":"https://jobs.lever.co/orcabiosystems/4f078d1e-aeaa-4ab3-adf2-143799eb6223","applyUrl":"https://jobs.lever.co/orcabiosystems/4f078d1e-aeaa-4ab3-adf2-143799eb6223/apply"},{"additionalPlain":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.\n \nWho we are\n \nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.\n \nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.\n \nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.\n \nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.\n \nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.\n \nNotice to staffing firms\n \nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.\n","additional":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
\n
\nWho we are
\n
\nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\nNotice to staffing firms
\n
\nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
","categories":{"commitment":"Regular, Full-Time Employee","department":"Manufacturing","location":"Sacramento, CA","team":"Production","allLocations":["Sacramento, CA"]},"createdAt":1774640336816,"descriptionPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n \nWe operate a dedicated clinical manufacturing facility in Sacramento, CA (3400 Business Drive), which has historically served as the foundation for producing our high-precision cell therapy products. This site plays a critical role in advancing our clinical pipeline and ensuring the consistent, reliable supply of therapies for patients participating in our trials.\n\n\nThis is a 2nd shift-based position, working on-site Monday through Friday, from 3pm to 11:30pm. Reporting into the assigned supervisor, clinical manufacturing, the Associate, Cell Therapy Production plays a critical role in the production of Orca's cell therapy products, ensuring adherence to strict quality standards, regulatory requirements and aseptic production techniques. This position involves repeatedly executing manufacturing processes, cleaning and maintaining production equipment and workstations and documenting production activities in a highly regulated environment. The role collaborates closely with Materials Management, Quality Control (QC), and Quality Assurance (QA) to carry out GMP manufacturing runs as part of a cross-functional team.\n","description":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\nWe operate a dedicated clinical manufacturing facility in Sacramento, CA (3400 Business Drive), which has historically served as the foundation for producing our high-precision cell therapy products. This site plays a critical role in advancing our clinical pipeline and ensuring the consistent, reliable supply of therapies for patients participating in our trials.
This is a 2nd shift-based position, working on-site Monday through Friday, from 3pm to 11:30pm. Reporting into the assigned supervisor, clinical manufacturing, the Associate, Cell Therapy Production plays a critical role in the production of Orca's cell therapy products, ensuring adherence to strict quality standards, regulatory requirements and aseptic production techniques. This position involves repeatedly executing manufacturing processes, cleaning and maintaining production equipment and workstations and documenting production activities in a highly regulated environment. The role collaborates closely with Materials Management, Quality Control (QC), and Quality Assurance (QA) to carry out GMP manufacturing runs as part of a cross-functional team.
","id":"e2243909-e813-4dc5-ae97-b2e598efaa77","lists":[{"text":"Physical Demands","content":"\nProduction Associates: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.\nMust be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.\n"},{"text":"Work Conditions","content":"\nMust be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.\nMust be comfortable regularly participating in video-based meetings.\nMay be required to work scheduled overtime, weekends, or holidays based on business needs.\n"},{"text":"Essential Duties & Key Responsibilities","content":"\nOperate and closely monitor advanced manufacturing equipment to support the production of cutting-edge cell therapy products\nFollow and execute standard operating procedures (SOPs) and batch records to perform production activities\nIdentify and resolve equipment or process issues, escalating to management as necessary\nComplete all assigned training to maintain required technical proficiency and adhere to cGMP standards\nOperate, monitor, clean, and prepare advanced automated equipment for cell processing, expansion, and filling in Grade B/C cleanroom environments. All required PPE and GMP-compliant gowning are provided by the company\nContribute to continuous improvement efforts, including manufacturing efficiency, compliance practices, and support for investigations, deviations, and change control processes\nRequired to participate in an on-call rotation as needed for weekend and/or holiday shifts\n"},{"text":"Minimum Qualifications","content":"\nB.S. degree required in biology or related field\n1-2 years of experience in process sciences, discovery research of manufacturing\nExperience with aseptic techniques\n"},{"text":"Preferred Qualifications","content":"\nM.S. degree in biology or related field\nPrior experience in GMP and lab-scale manufacturing, including validation and quality systems\nFamiliarity with cell/gene therapy, including working with human cells, cell characterization methods, sorting and analyzing cells\nAseptic techniques\n"},{"text":"Personal Qualities","content":"\nHighly detail oriented with special attention to quality and documentation\nStrong work ethic, curiosity to learn and contribute in a fast-paced, collaborative environment \nExcellent interpersonal skills and ability to communicate effectively\nAbility to work both independently and in a collaborative manner\nHighly tolerant and respectful of all team members\nA sense of humor is always appreciated\n"}],"salaryRange":{"currency":"USD","interval":"per-hour-wage","min":23,"max":28},"salaryDescription":"This position is eligible for shift-differential pay of +7%!
","salaryDescriptionPlain":"This position is eligible for shift-differential pay of +7%!\n","text":"Associate, Cell Therapy Production, 2nd Shift","country":"US","workplaceType":"onsite","opening":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\nWe operate a dedicated clinical manufacturing facility in Sacramento, CA (3400 Business Drive), which has historically served as the foundation for producing our high-precision cell therapy products. This site plays a critical role in advancing our clinical pipeline and ensuring the consistent, reliable supply of therapies for patients participating in our trials.
","openingPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n \nWe operate a dedicated clinical manufacturing facility in Sacramento, CA (3400 Business Drive), which has historically served as the foundation for producing our high-precision cell therapy products. This site plays a critical role in advancing our clinical pipeline and ensuring the consistent, reliable supply of therapies for patients participating in our trials.\n","descriptionBody":"This is a 2nd shift-based position, working on-site Monday through Friday, from 3pm to 11:30pm. Reporting into the assigned supervisor, clinical manufacturing, the Associate, Cell Therapy Production plays a critical role in the production of Orca's cell therapy products, ensuring adherence to strict quality standards, regulatory requirements and aseptic production techniques. This position involves repeatedly executing manufacturing processes, cleaning and maintaining production equipment and workstations and documenting production activities in a highly regulated environment. The role collaborates closely with Materials Management, Quality Control (QC), and Quality Assurance (QA) to carry out GMP manufacturing runs as part of a cross-functional team.
","descriptionBodyPlain":"This is a 2nd shift-based position, working on-site Monday through Friday, from 3pm to 11:30pm. Reporting into the assigned supervisor, clinical manufacturing, the Associate, Cell Therapy Production plays a critical role in the production of Orca's cell therapy products, ensuring adherence to strict quality standards, regulatory requirements and aseptic production techniques. This position involves repeatedly executing manufacturing processes, cleaning and maintaining production equipment and workstations and documenting production activities in a highly regulated environment. The role collaborates closely with Materials Management, Quality Control (QC), and Quality Assurance (QA) to carry out GMP manufacturing runs as part of a cross-functional team.\n","hostedUrl":"https://jobs.lever.co/orcabiosystems/e2243909-e813-4dc5-ae97-b2e598efaa77","applyUrl":"https://jobs.lever.co/orcabiosystems/e2243909-e813-4dc5-ae97-b2e598efaa77/apply"},{"additionalPlain":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.\n \nWho we are\n \nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.\n \nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.\n \nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.\n \nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.\n \nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.\n \nNotice to staffing firms\n \nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.\n","additional":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
\n
\nWho we are
\n
\nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\nNotice to staffing firms
\n
\nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
","categories":{"commitment":"Regular, Full-Time Employee","department":"Manufacturing","location":"Sacramento, CA","team":"Planning, Materials & Procurement","allLocations":["Sacramento, CA"]},"createdAt":1772823066349,"descriptionPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n\n\nThe Associate, Packaging Operations and Cold Chain Handling - Night Shift supports critical operations related to the receipt of patient materials (leukapheresis/blood), cryopreservation of cellular products, and preparation and coordination of final drug product shipments. This role will operate with a deep understanding of GMP manufacturing, cell therapy processes, and the ability to execute multiple tasks in a fast-paced environment.\n \nNight Shift Hours Worked:\n• 6:00pm to 6:30am or\n• 6:30pm to 7:00am\n \nWork Week Schedule:\n• Sunday, Monday, Tuesday + every other Wednesday or\n• Thursday, Friday, Saturday + every other Wednesday \n","description":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
The Associate, Packaging Operations and Cold Chain Handling - Night Shift supports critical operations related to the receipt of patient materials (leukapheresis/blood), cryopreservation of cellular products, and preparation and coordination of final drug product shipments. This role will operate with a deep understanding of GMP manufacturing, cell therapy processes, and the ability to execute multiple tasks in a fast-paced environment.
\n
\nNight Shift Hours Worked:
\n• 6:00pm to 6:30am or
\n• 6:30pm to 7:00am
\n
\nWork Week Schedule:
\n• Sunday, Monday, Tuesday + every other Wednesday or
\n• Thursday, Friday, Saturday + every other Wednesday
","id":"392f9cc9-9ec3-4e26-9640-d901628c67ae","lists":[{"text":"Physical Demands","content":"\nProduction Associate Roles: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.\nMust be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.\n"},{"text":"Work Conditions","content":"\nMust be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.\nMust be comfortable regularly participating in video-based meetings.\nMay be required to work scheduled overtime, weekends, or holidays based on business needs.\n"},{"text":"Essential Duties & Key Responsibilities","content":"\nBlood Intake & Chain-of-Identity Management:\nReceive and verify incoming apheresis materials according to SOPs and regulatory requirements. \nPerform visual inspections and documentation checks to ensure proper labeling, temperature, and packaging. \n Maintain strict adherence to chain-of-identity and chain-of-custody procedures. \nCryopreservation Support: \nAssist in the preparation and cryopreservation of intermediate and final cellular products. \nOperate and maintain cryogenic storage equipment (e.g., controlled-rate freezers, LN2 tanks). \nAccurately complete batch records and electronic documentation systems. \nDrug Product Shipment: \nCoordinate the labeling, packaging, and final release of drug product for shipment. \nPrepare shipping materials, confirm shipping conditions (e.g., temperature control), and liaise with logistics partners. \nEnsure real-time data entry into inventory, tracking systems and eBRs \nPerform other duties as assigned \nWork closely with Quality Assurance, Supply Chain, and Manufacturing teams to ensure timely and compliant operations. \nSupport deviation investigations, CAPAs, and continuous improvement initiatives as needed. \nMaintain accurate and complete records in accordance with GMP and GDP standards. \nGood Manufacturing Practices (GMP) Training \n"},{"text":"Minimum Qualifications","content":"\nBachelor’s degree in Life Sciences, Engineering, or related field preferred. \n1-3 years of experience in a GMP-regulated biotech or pharmaceutical environment preferred. \nStrong understanding of cell therapy manufacturing processes \nStrong attention to detail, organizational skills and document accuracy. \nAbility to work with biological materials and cryogenic systems \nKnowledge of regulatory compliance (FDA and GxP) a plus \nComfortable working in a clean room and or cold environment (Liquid Nitrogen storage) \n"},{"text":"Travel Requirements and Work Environment ","content":"\nDomestic and international travel not required \nMay involve standing for extended periods and lifting up to 25 lbs \nShift work, weekends, or holidays may be required depending on production needs \nExposure to human blood products and temperature-controlled storage areas \nGowning and use of Personal Protective Equipment required \n"}],"salaryRange":{"min":65465,"max":71571,"currency":"USD","interval":"per-year-salary"},"salaryDescription":"Base hourly pay range: $24–$26. The annualized earnings range above reflects estimated scheduled overtime and a +10% night shift differential. Total compensation will vary based on assigned shift, overtime worked, and applicable differentials.
","salaryDescriptionPlain":"Base hourly pay range: $24–$26. The annualized earnings range above reflects estimated scheduled overtime and a +10% night shift differential. Total compensation will vary based on assigned shift, overtime worked, and applicable differentials.\n","text":"Associate, Packaging Operations and Cold Chain Handling - Night Shift","country":"US","workplaceType":"onsite","opening":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.The Associate, Packaging Operations and Cold Chain Handling - Night Shift supports critical operations related to the receipt of patient materials (leukapheresis/blood), cryopreservation of cellular products, and preparation and coordination of final drug product shipments. This role will operate with a deep understanding of GMP manufacturing, cell therapy processes, and the ability to execute multiple tasks in a fast-paced environment.
\n
\nNight Shift Hours Worked:
\n• 6:00pm to 6:30am or
\n• 6:30pm to 7:00am
\n
\nWork Week Schedule:
\n• Sunday, Monday, Tuesday + every other Wednesday or
\n• Thursday, Friday, Saturday + every other Wednesday
","descriptionBodyPlain":"The Associate, Packaging Operations and Cold Chain Handling - Night Shift supports critical operations related to the receipt of patient materials (leukapheresis/blood), cryopreservation of cellular products, and preparation and coordination of final drug product shipments. This role will operate with a deep understanding of GMP manufacturing, cell therapy processes, and the ability to execute multiple tasks in a fast-paced environment.\n \nNight Shift Hours Worked:\n• 6:00pm to 6:30am or\n• 6:30pm to 7:00am\n \nWork Week Schedule:\n• Sunday, Monday, Tuesday + every other Wednesday or\n• Thursday, Friday, Saturday + every other Wednesday \n","hostedUrl":"https://jobs.lever.co/orcabiosystems/392f9cc9-9ec3-4e26-9640-d901628c67ae","applyUrl":"https://jobs.lever.co/orcabiosystems/392f9cc9-9ec3-4e26-9640-d901628c67ae/apply"},{"additionalPlain":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.\n \nWho we are\n \nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.\n \nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.\n \nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.\n \nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.\n \nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.\n \nNotice to staffing firms\n \nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.\n","additional":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
\n
\nWho we are
\n
\nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\nNotice to staffing firms
\n
\nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
","categories":{"commitment":"Regular, Full-Time Employee","department":"Manufacturing","location":"Sacramento, CA","team":"Production","allLocations":["Sacramento, CA"]},"createdAt":1772209308642,"descriptionPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n\n\nThe Cell Therapy Production Associate, Oncology - Night Shift plays a critical role in the production of Orca Bio’s life-saving cell therapy products, ensuring adherence to strict quality standards, regulatory requirements and aseptic production techniques. Reporting into the assigned supervisor, commercial manufacturing, the job involves repeatedly executing manufacturing processes, cleaning and maintaining production equipment and workstations and documenting production activities in a highly regulated environment. The role collaborates closely with Materials Management, Quality Control (QC), and Quality Assurance (QA) to carry out GMP manufacturing runs as part of a cross-functional team.\n \nNight Shift Hours Worked:\n• 6:00pm to 6:30am or\n• 6:30pm to 7:00am\n \nWork Week Schedule:\n• Sunday, Monday, Tuesday + every other Wednesday or\n• Thursday, Friday, Saturday + every other Wednesday\n","description":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
The Cell Therapy Production Associate, Oncology - Night Shift plays a critical role in the production of Orca Bio’s life-saving cell therapy products, ensuring adherence to strict quality standards, regulatory requirements and aseptic production techniques. Reporting into the assigned supervisor, commercial manufacturing, the job involves repeatedly executing manufacturing processes, cleaning and maintaining production equipment and workstations and documenting production activities in a highly regulated environment. The role collaborates closely with Materials Management, Quality Control (QC), and Quality Assurance (QA) to carry out GMP manufacturing runs as part of a cross-functional team.
\n
\nNight Shift Hours Worked:
\n• 6:00pm to 6:30am or
\n• 6:30pm to 7:00am
\n
\nWork Week Schedule:
\n• Sunday, Monday, Tuesday + every other Wednesday or
\n• Thursday, Friday, Saturday + every other Wednesday
","id":"c193afd8-b3f8-4939-bcae-79e5d24263f5","lists":[{"text":"Physical and Work Demands","content":"\nProduction Associate Roles: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.\nMust be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.\nMust be comfortable regularly participating in video-based meetings.\nSchedules, as noted, include daily overtime, Saturday or Sunday work and holidays.\n"},{"text":"Key Responsibilities","content":"\nOperate and closely monitor advanced manufacturing equipment to support the production of cutting-edge cell therapy products\nFollow and execute standard operating procedures (SOPs) and batch records to perform production activities\nIdentify and resolve equipment or process issues, escalating to management as necessary\nComplete all assigned training to maintain required technical proficiency and adhere to cGMP standards\nOperate, monitor, clean, and prepare advanced automated equipment for cell processing, expansion, and filling in Grade B/C cleanroom environments. All required PPE and GMP-compliant gowning are provided by the company\nContribute to continuous improvement efforts, including manufacturing efficiency, compliance practices, and support for investigations, deviations, and change control processes\n"},{"text":"Minimum Qualifications","content":"\nAssociate degree and at least 1 year of experience in biomanufacturing, OR\nHigh School Diploma/GED with a minimum of 2 years of biomanufacturing experience\n"},{"text":"Preferred Qualifications","content":"\nExperience working in GMP-compliant environments\nInvolvement in investigations, deviations, and change control processes\nB.S. degree in Biological or related sciences\n"},{"text":"Personal Qualities","content":"\nHighly detail oriented with special attention to quality and documentation\nStrong work ethic, curiosity to learn and contribute in a fast-paced, collaborative environment \nExcellent interpersonal skills and ability to communicate effectively\nAbility to work both independently and in a collaborative manner\nHighly tolerant and respectful of all team members\n"}],"salaryRange":{"min":65465,"currency":"USD","interval":"per-year-salary","max":71571},"salaryDescription":"Base hourly pay range: $24–$26. The annualized earnings range above reflects estimated scheduled overtime and a +10% night shift differential. Total compensation will vary based on assigned shift, overtime worked, and applicable differentials.
","salaryDescriptionPlain":"Base hourly pay range: $24–$26. The annualized earnings range above reflects estimated scheduled overtime and a +10% night shift differential. Total compensation will vary based on assigned shift, overtime worked, and applicable differentials.\n","text":"Cell Therapy Production Associate, Oncology - Night Shift","country":"US","workplaceType":"onsite","opening":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.The Cell Therapy Production Associate, Oncology - Night Shift plays a critical role in the production of Orca Bio’s life-saving cell therapy products, ensuring adherence to strict quality standards, regulatory requirements and aseptic production techniques. Reporting into the assigned supervisor, commercial manufacturing, the job involves repeatedly executing manufacturing processes, cleaning and maintaining production equipment and workstations and documenting production activities in a highly regulated environment. The role collaborates closely with Materials Management, Quality Control (QC), and Quality Assurance (QA) to carry out GMP manufacturing runs as part of a cross-functional team.
\n
\nNight Shift Hours Worked:
\n• 6:00pm to 6:30am or
\n• 6:30pm to 7:00am
\n
\nWork Week Schedule:
\n• Sunday, Monday, Tuesday + every other Wednesday or
\n• Thursday, Friday, Saturday + every other Wednesday
","descriptionBodyPlain":"The Cell Therapy Production Associate, Oncology - Night Shift plays a critical role in the production of Orca Bio’s life-saving cell therapy products, ensuring adherence to strict quality standards, regulatory requirements and aseptic production techniques. Reporting into the assigned supervisor, commercial manufacturing, the job involves repeatedly executing manufacturing processes, cleaning and maintaining production equipment and workstations and documenting production activities in a highly regulated environment. The role collaborates closely with Materials Management, Quality Control (QC), and Quality Assurance (QA) to carry out GMP manufacturing runs as part of a cross-functional team.\n \nNight Shift Hours Worked:\n• 6:00pm to 6:30am or\n• 6:30pm to 7:00am\n \nWork Week Schedule:\n• Sunday, Monday, Tuesday + every other Wednesday or\n• Thursday, Friday, Saturday + every other Wednesday\n","hostedUrl":"https://jobs.lever.co/orcabiosystems/c193afd8-b3f8-4939-bcae-79e5d24263f5","applyUrl":"https://jobs.lever.co/orcabiosystems/c193afd8-b3f8-4939-bcae-79e5d24263f5/apply"},{"additionalPlain":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.\n \nWho we are\n \nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.\n \nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.\n \nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.\n \nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.\n \nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.\n \nNotice to staffing firms\n \nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.\n","additional":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
\n
\nWho we are
\n
\nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\nNotice to staffing firms
\n
\nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
","categories":{"commitment":"Regular, Full-Time Employee","department":"All Teams","location":"Menlo Park, CA","team":"All Teams","allLocations":["Menlo Park, CA"]},"createdAt":1780618557196,"descriptionPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n\n\nOrca Bio is at a transformative juncture. With our lead cell therapy candidate, Orca-T, approaching a critical PDUFA date and our 2nd-generation platform, Orca-Q, expanding its clinical footprint, we are transitioning from a development-focused biotechnology company to a commercial-stage leader.\nTo support this next phase of growth, we are seeking a highly organized, analytical, and hands-on Chief of Staff to the CEO and President. Operating at the intersection of leadership priorities, the Chief of Staff will help improve organizational effectiveness, facilitate cross-functional execution, and support the successful delivery of the company's most important strategic initiatives.\nThis is a low-ego, high-impact role that requires someone who can seamlessly shift between long-term strategic thinking and immediate tactical execution. The ideal candidate excels at solving complex problems, coordinating across diverse stakeholders, and driving progress in situations where ownership spans multiple functions.\nThe Chief of Staff is not a functional leader and does not assume decision-making authority over existing departments. Success in this role depends on influence, collaboration, and partnership with the Executive Team to improve alignment, communication, and execution across the organization.\n","description":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\n
Orca Bio is at a transformative juncture. With our lead cell therapy candidate, Orca-T, approaching a critical PDUFA date and our 2nd-generation platform, Orca-Q, expanding its clinical footprint, we are transitioning from a development-focused biotechnology company to a commercial-stage leader.
\n
To support this next phase of growth, we are seeking a highly organized, analytical, and hands-on Chief of Staff to the CEO and President. Operating at the intersection of leadership priorities, the Chief of Staff will help improve organizational effectiveness, facilitate cross-functional execution, and support the successful delivery of the company's most important strategic initiatives.
\n
This is a low-ego, high-impact role that requires someone who can seamlessly shift between long-term strategic thinking and immediate tactical execution. The ideal candidate excels at solving complex problems, coordinating across diverse stakeholders, and driving progress in situations where ownership spans multiple functions.
\n
The Chief of Staff is not a functional leader and does not assume decision-making authority over existing departments. Success in this role depends on influence, collaboration, and partnership with the Executive Team to improve alignment, communication, and execution across the organization.
\n
Executive Support & Operational Execution:
\n\n- Manage a diverse portfolio of executive requests, operational priorities, and strategic initiatives.
\n- Coordinate preparation for executive meetings, Board of Directors meetings, and key business reviews, ensuring discussions remain focused on decisions, risks, and priorities.
\n- Synthesize information from across the organization and prepare executive communications, presentations, and decision-support materials.
\n- Serve as a coordination point between the CEO, President, and other Executive Team members by facilitating communication, tracking key actions, and supporting follow-through on agreed priorities.
\n- Support special initiatives and operational needs that do not naturally fall within a single functional area.
\n\nStrategic Initiatives & Cross-Functional Coordination:
\n
"},{"text":"Qualifications","content":"\n- Bachelor's degree required; advanced degree in science or business is a plus.
\n- Minimum 5-8 years of professional experience in consulting, market research, business operations, strategy, or a related field, with direct experience in the biotechnology, healthcare, or pharmaceutical industry.
\n- Demonstrated ability to manage complex cross-functional initiatives involving multiple stakeholders and competing priorities.
\n- Highly analytical, combining humility, sound judgment, and a relentless focus on execution.
\n- Exceptional written communication and presentation development capabilities.
\n- Proven ability to build relationships across all levels of an organization.
\n- Highly organized with strong project management skills and attention to detail.
\n- Comfortable operating in both strategic and highly tactical environments.
\n- Demonstrated sound judgment, professionalism, discretion, and a strong sense of ownership.
\n
"}],"salaryRange":{"min":150000,"max":230000,"currency":"USD","interval":"per-year-salary"},"text":"Chief of Staff to CEO and President","country":"US","workplaceType":"onsite","opening":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n
Orca Bio is at a transformative juncture. With our lead cell therapy candidate, Orca-T, approaching a critical PDUFA date and our 2nd-generation platform, Orca-Q, expanding its clinical footprint, we are transitioning from a development-focused biotechnology company to a commercial-stage leader.
\n
To support this next phase of growth, we are seeking a highly organized, analytical, and hands-on Chief of Staff to the CEO and President. Operating at the intersection of leadership priorities, the Chief of Staff will help improve organizational effectiveness, facilitate cross-functional execution, and support the successful delivery of the company's most important strategic initiatives.
\n
This is a low-ego, high-impact role that requires someone who can seamlessly shift between long-term strategic thinking and immediate tactical execution. The ideal candidate excels at solving complex problems, coordinating across diverse stakeholders, and driving progress in situations where ownership spans multiple functions.
\n
The Chief of Staff is not a functional leader and does not assume decision-making authority over existing departments. Success in this role depends on influence, collaboration, and partnership with the Executive Team to improve alignment, communication, and execution across the organization.
\n
The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
\n
\nWho we are
\n
\nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\nNotice to staffing firms
\n
\nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
","categories":{"commitment":"Regular, Full-Time Employee","department":"Manufacturing","location":"Sacramento, CA","team":"Production","allLocations":["Sacramento, CA"]},"createdAt":1775600895145,"descriptionPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n \nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.\n\n\nThe Director, Commercial Manufacturing is responsible for leadership of cell therapy manufacturing operations and production support functions to ensure reliable, compliant, and timely delivery of patient-specific therapies. This role drives consistent batch execution, operational discipline, and cross-functional alignment to meet on-time patient delivery while maintaining the highest standards of quality and safety.\nThe Director will build and sustain robust production systems, embed lean manufacturing principles, and lead continuous improvement initiatives to scale operations in a dynamic, GMP-regulated environment.\n","description":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
The Director, Commercial Manufacturing is responsible for leadership of cell therapy manufacturing operations and production support functions to ensure reliable, compliant, and timely delivery of patient-specific therapies. This role drives consistent batch execution, operational discipline, and cross-functional alignment to meet on-time patient delivery while maintaining the highest standards of quality and safety.
\nThe Director will build and sustain robust production systems, embed lean manufacturing principles, and lead continuous improvement initiatives to scale operations in a dynamic, GMP-regulated environment.
","id":"09dec941-34b4-4e14-9396-5a3439dbe773","lists":[{"text":"Physical Demands","content":"\nProduction Associate Roles: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.\nMost roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.\n"},{"text":"Work Conditions","content":"\nMany roles must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video-based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs.\n"},{"text":"Essential Duties & Key Responsibilities:","content":"\n\n
Commercial Manufacturing Oversight\n\n- Provide strategic and day-to-day leadership for GMP manufacturing operations
\n- Ensure consistent execution of manufacturing batches in alignment with production schedules and patient needs
\n- Drive right-first-time execution and minimize deviations, batch failures, and delays
\n- Ensure rapid resolution of manufacturing issues with minimal impact to patients
\n\n\n- Patient-Centric Delivery Execution\n
\n- Own manufacturing performance metrics tied to patient delivery:\n
\n- On-time batch release and shipment
\n- Cycle time adherence
\n- Schedule attainment
\n\n\n- Partner cross-functionally with Quality, Supply Chain, and Patient Operations to ensure seamless delivery of autologous therapies
\n\n\n- Quality and Compliance\n
\n- Ensure full compliance with cGMP, regulatory requirements, and internal quality systems
\n- Partner closely with Quality Assurance to:\n
\n- Drive deviation reduction and investigation closure
\n- Maintain inspection readiness
\n- Support audits and regulatory inspections
\n\n\n- Promote a strong quality culture and accountability at all levels
\n\n\n- Safety Leadership\n
\n- Champion a culture of safety across manufacturing operations
\n- Ensure compliance with EHS requirements and proactively mitigate risks
\n- Lead investigations and corrective actions for safety incidents
\n\n\n- Lean Manufacturing and Continuous Improvement\n
\n- Establish and sustain lean manufacturing systems, including:\n
\n- Visual management
\n- Standard work
\n- Tiered accountability
\n- Daily performance management
\n\n\n- Lead continuous improvement initiatives to enhance:\n
\n- Throughput
\n- Capacity utilization
\n- Cost efficiency
\n- Process robustness
\n\n\n- Utilize data-driven decision-making and performance dashboards
\n\n\n- People Leadership and Development\n
\n- Build, lead, and develop high-performing teams across manufacturing and support functions
\n- Establish clear goals, performance expectations, and accountability structures
\n- Foster a culture of engagement, ownership, and continuous learning
\n\n\n\n
More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
","openingPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n \nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.\n","descriptionBody":"The Director, Commercial Manufacturing is responsible for leadership of cell therapy manufacturing operations and production support functions to ensure reliable, compliant, and timely delivery of patient-specific therapies. This role drives consistent batch execution, operational discipline, and cross-functional alignment to meet on-time patient delivery while maintaining the highest standards of quality and safety.
\nThe Director will build and sustain robust production systems, embed lean manufacturing principles, and lead continuous improvement initiatives to scale operations in a dynamic, GMP-regulated environment.
","descriptionBodyPlain":"The Director, Commercial Manufacturing is responsible for leadership of cell therapy manufacturing operations and production support functions to ensure reliable, compliant, and timely delivery of patient-specific therapies. This role drives consistent batch execution, operational discipline, and cross-functional alignment to meet on-time patient delivery while maintaining the highest standards of quality and safety.\nThe Director will build and sustain robust production systems, embed lean manufacturing principles, and lead continuous improvement initiatives to scale operations in a dynamic, GMP-regulated environment.\n","hostedUrl":"https://jobs.lever.co/orcabiosystems/09dec941-34b4-4e14-9396-5a3439dbe773","applyUrl":"https://jobs.lever.co/orcabiosystems/09dec941-34b4-4e14-9396-5a3439dbe773/apply"},{"additionalPlain":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.\n \nWho we are\n \nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.\n \nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.\n \nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.\n \nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.\n \nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.\n \nNotice to staffing firms\n \nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.\n","additional":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
\n
\nWho we are
\n
\nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\nNotice to staffing firms
\n
\nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
","categories":{"commitment":"Regular, Full-Time Employee","department":"Commercial","location":"Remote","team":"Marketing","allLocations":["Remote","Menlo Park, CA","Sacramento, CA"]},"createdAt":1775576614574,"descriptionPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n\n\nSummary: The Director, Marketing is responsible for leading the US promotional launch of Orca-T, Orca Bio’s first commercial product. This individual will be a critical member of the Marketing team and broader Commercial team, leading workstreams to collect and interpret HCP insights, develop engagement strategies, shape and test Brand messaging, and build promotional tactics. The Director, Marketing will have a wide remit including HCP, payer, and patient audiences, personal and non-personal tactical development, and omnichannel media strategy. Planning for multiple launch scenarios, completing promotional readiness, and contributing to Commercial and organizational Launch Readiness will be core responsibilities for this role. Reporting into the VP/Head of Marketing, this individual will collaborate closely with the cross-functional Orca team including Medical Affairs, Sales, Operations, Regulatory, IT, and Legal.\n","description":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
Summary: The Director, Marketing is responsible for leading the US promotional launch of Orca-T, Orca Bio’s first commercial product. This individual will be a critical member of the Marketing team and broader Commercial team, leading workstreams to collect and interpret HCP insights, develop engagement strategies, shape and test Brand messaging, and build promotional tactics. The Director, Marketing will have a wide remit including HCP, payer, and patient audiences, personal and non-personal tactical development, and omnichannel media strategy. Planning for multiple launch scenarios, completing promotional readiness, and contributing to Commercial and organizational Launch Readiness will be core responsibilities for this role. Reporting into the VP/Head of Marketing, this individual will collaborate closely with the cross-functional Orca team including Medical Affairs, Sales, Operations, Regulatory, IT, and Legal.
","id":"9e6b202a-16de-4a94-b01d-72a1811467a8","lists":[{"text":"Responsibilities","content":"\n
\n- Leads the promotional launch of Orca-T, driving robust pre-launch, launch, and post-launch strategies and omnichannel tactics that maximize market penetration and product adoption
\n- Drives development of unique and effective HCP engagement strategies aligned to Orca-T Brand strategy
\n- Collaborate with the Market Development team and other Commercial personnel to shape a comprehensive HCP Marketing tactical plan, budget, and performance plan aligned to Brand KPIs to enable a robust promotional launch
\n- Lead Orca-T message development across HCP and patient audiences, including insights generation and analysis
\n- Lead the execution of a full HCP-facing tactical suite for personal and non-personal channels, including PRC review and approval, for Day 0, Now Approved, and Campaign assets
\n- Contribute to omnichannel strategy, deployment, and management
\n- Manage agency partners effectively to deliver consistent results
\n- Contribute to advisory board content, execution, and analysis
\n- KOL Engagement at major congresses, advisory boards, and site visits as necessary to support Commercial onboarding workstreams
\n- Lead consistent engagement with Sales team to ensure optimization of messaging and assets
\n- Effectively manage the promotions tactical budget to Launch Readiness and Orca-T launch
\n- Manage one Product Marketing FTE
\n\n
\n
\n- Bachelor’s degree in Life Sciences, Marketing, Finance, or related required; an MBA or other advanced degree is preferred
\n- 10 years of biopharmaceutical experience, including at least 7 years of experience in Marketing, Commercial Strategy, and/or Sales
\n- Experience in hematology/oncology and/or bone marrow transplantation and marketing complex, novel products in therapeutic areas of high unmet need
\n- Proven ability to prioritize and manage multiple projects simultaneously, including market research, message development, promotional tactics, advertising campaigns, and associated PRC and OPDP processes
\n- Track record of cross-functional collaboration
\n- Prior people management experience preferred
\n- Willingness to travel up to 20%
\n\n
\n
\n- Strong Marketing experience, including unbranded and branded strategy and tactical execution
\n- Experience building and managing omnichannel tactics, including digital and print media
\n- Clinically proficient in acute leukemia and bone marrow transplantation, with a track-record of working with clinical and scientific experts in-house and externally to shape strategy and tactics
\n- Strong business acumen and insight into HCP perception/behavior dynamics and key value drivers
\n- Expertise in prioritizing and managing multiple projects simultaneously to deliver against ambitious goals
\n- Strong communication skills, with the ability to educate internal stakeholders about Marketing best-practices while driving results
\n- Able to thrive in dynamic, ambiguous environments and champion an entrepreneurial mindset
\n- Thrives in a fast-moving, dynamic environment
\n- Proficiency with Veeva PromoMats preferred
\n\n
More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.Summary: The Director, Marketing is responsible for leading the US promotional launch of Orca-T, Orca Bio’s first commercial product. This individual will be a critical member of the Marketing team and broader Commercial team, leading workstreams to collect and interpret HCP insights, develop engagement strategies, shape and test Brand messaging, and build promotional tactics. The Director, Marketing will have a wide remit including HCP, payer, and patient audiences, personal and non-personal tactical development, and omnichannel media strategy. Planning for multiple launch scenarios, completing promotional readiness, and contributing to Commercial and organizational Launch Readiness will be core responsibilities for this role. Reporting into the VP/Head of Marketing, this individual will collaborate closely with the cross-functional Orca team including Medical Affairs, Sales, Operations, Regulatory, IT, and Legal.
","descriptionBodyPlain":"Summary: The Director, Marketing is responsible for leading the US promotional launch of Orca-T, Orca Bio’s first commercial product. This individual will be a critical member of the Marketing team and broader Commercial team, leading workstreams to collect and interpret HCP insights, develop engagement strategies, shape and test Brand messaging, and build promotional tactics. The Director, Marketing will have a wide remit including HCP, payer, and patient audiences, personal and non-personal tactical development, and omnichannel media strategy. Planning for multiple launch scenarios, completing promotional readiness, and contributing to Commercial and organizational Launch Readiness will be core responsibilities for this role. Reporting into the VP/Head of Marketing, this individual will collaborate closely with the cross-functional Orca team including Medical Affairs, Sales, Operations, Regulatory, IT, and Legal.\n","hostedUrl":"https://jobs.lever.co/orcabiosystems/9e6b202a-16de-4a94-b01d-72a1811467a8","applyUrl":"https://jobs.lever.co/orcabiosystems/9e6b202a-16de-4a94-b01d-72a1811467a8/apply"},{"additionalPlain":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.\n \nWho we are\n \nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.\n \nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.\n \nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.\n \nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.\n \nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.\n \nNotice to staffing firms\n \nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.\n","additional":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
\n
\nWho we are
\n
\nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\nNotice to staffing firms
\n
\nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
","categories":{"commitment":"Regular, Full-Time Employee","department":"Engineering","location":"Sacramento, CA","team":"MSAT","allLocations":["Sacramento, CA"]},"createdAt":1772121582813,"descriptionPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n \nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.\n\n\nThe Engineer, MSAT works to improve the efficiency and safety of the drug product manufacturing process. This role is responsible for life cycle management of commercial products including process monitoring and troubleshooting, implementation and validation of process improvements and changes, and supporting investigations and corrective/preventive actions. \n","description":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
The Engineer, MSAT works to improve the efficiency and safety of the drug product manufacturing process. This role is responsible for life cycle management of commercial products including process monitoring and troubleshooting, implementation and validation of process improvements and changes, and supporting investigations and corrective/preventive actions.
","id":"4c0e97ab-b525-42f4-bade-4f2d402fd51a","lists":[{"text":"Physical Demands","content":"\nProduction Associate Roles: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.\nMost roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.\n"},{"text":"Work Conditions","content":"\nMany roles must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video-based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs.\n"},{"text":"Essential Duties & Key Responsibilities:","content":"\nPerforms ongoing monitoring of existing commercial products and processes \nGenerate metrics and reports for process monitoring and continuous process verification \nSupport process improvements and changes including electronic batch record creation and modifications \nPerforms Out of Trend Investigations based on trends from process monitoring\nProvides troubleshooting support for manufacturing events, equipment performance and material issues \nPerforms root cause analysis to isolate cause of events and determine appropriate corrective actions \nAuthors and owns change controls, technical protocols, reports and activities to support process improvements \nWrites and ensures proper execution of validation protocols and testing in line with required life cycle management activities \nLeads design, project management and execution of MSAT projects, introduction of new materials, and equipment at multiple GMP facilities\nAssess potential impact of supplier changes, material changes, Drug product labels, Drug Product packaging and cold chain transport changes and excursions\n"},{"text":"Minimum Qualifications:","content":"\nB.S. in Engineering or similar fields \n3+ years of experience with manufacturing processes and equipment in related fields: biologics, pharmaceutical fill and finish or drug substance manufacturing, Chemical or food industries \nPrior experience in regulated, GMP manufacturing operations\nExperience with data analysis and trending using JMP or other statistical software \nFollow cleanroom protocols, e.g. no cosmetics including make-up, painted nails, jewelry or piercings, and must disclose any shedding skin condition \n"},{"text":"Preferred Qualifications: ","content":"\nExperience in biotechnology and cell therapy manufacturing preferred \nExperience with commercial packaging, labeling, and cold chain strongly preferred\nExcellent communication and problem solving skills, with a desire to improve upon established processes \n"}],"salaryRange":{"currency":"USD","interval":"per-year-salary","min":85000,"max":105000},"text":"Engineer, Manufacturing Sciences & Technology (MSAT)","country":"US","workplaceType":"onsite","opening":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
","openingPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n \nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.\n","descriptionBody":"The Engineer, MSAT works to improve the efficiency and safety of the drug product manufacturing process. This role is responsible for life cycle management of commercial products including process monitoring and troubleshooting, implementation and validation of process improvements and changes, and supporting investigations and corrective/preventive actions.
","descriptionBodyPlain":"The Engineer, MSAT works to improve the efficiency and safety of the drug product manufacturing process. This role is responsible for life cycle management of commercial products including process monitoring and troubleshooting, implementation and validation of process improvements and changes, and supporting investigations and corrective/preventive actions. \n","hostedUrl":"https://jobs.lever.co/orcabiosystems/4c0e97ab-b525-42f4-bade-4f2d402fd51a","applyUrl":"https://jobs.lever.co/orcabiosystems/4c0e97ab-b525-42f4-bade-4f2d402fd51a/apply"},{"additionalPlain":"Who we are\n \nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.\n \nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.\n \nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.\n \nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.\n \nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.\n \nNotice to staffing firms\n \nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.\n","additional":"Who we are
\n
\nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\nNotice to staffing firms
\n
\nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
","categories":{"department":"All Teams","location":"Sacramento, CA","team":"All Teams","allLocations":["Sacramento, CA","Menlo Park, CA"]},"createdAt":1744319394406,"descriptionPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n \nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.\n\n\nDidn’t find an open role that feels like the perfect fit? We’d still like to hear from you. Orca Bio is growing fast, and we’re always looking for passionate, driven people who want to help us transform the future of cell therapy at our Bay Area and Sacramento sites (and in some cases, remote/field based).\n\nThis general application is a way for you to introduce yourself to our Recruiting Team. Please submit your resume and a brief description letting us know your areas of interest and how you'd like to contribute at Orca Bio. We’ll keep your information on file and reach out if something aligns now—or in the future.\n\nThanks for your interest in joining the pod!\n\nWhat We Offer\n\nYou may be eligible to receive pre-IPO equity, in addition to:\n- Competitive medical, dental, and vision benefits\n- Flexible PTO and paid holidays\n- 401(k) plan\n- Life and accidental death & disability coverage\n- Parental leave benefits\n- Free daily lunches and snacks at our on-site locations\n","description":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
Didn’t find an open role that feels like the perfect fit? We’d still like to hear from you. Orca Bio is growing fast, and we’re always looking for passionate, driven people who want to help us transform the future of cell therapy at our Bay Area and Sacramento sites (and in some cases, remote/field based).
This general application is a way for you to introduce yourself to our Recruiting Team. Please submit your resume and a brief description letting us know your areas of interest and how you'd like to contribute at Orca Bio. We’ll keep your information on file and reach out if something aligns now—or in the future.
Thanks for your interest in joining the pod!
What We Offer
You may be eligible to receive pre-IPO equity, in addition to:
- Competitive medical, dental, and vision benefits
- Flexible PTO and paid holidays
- 401(k) plan
- Life and accidental death & disability coverage
- Parental leave benefits
- Free daily lunches and snacks at our on-site locations
","id":"5019118e-ad1b-44d3-8e1d-bfb921772b93","lists":[{"text":"Physical Demands","content":"\nProduction Associates: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.\nMust be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.\n"},{"text":"Work Conditions","content":"\nMust be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.\nMust be comfortable regularly participating in video-based meetings.\nMay be required to work scheduled overtime, weekends, or holidays based on business needs.\n"}],"text":"Join Our Talent Community","country":"US","workplaceType":"onsite","opening":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
","openingPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n \nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.\n","descriptionBody":"Didn’t find an open role that feels like the perfect fit? We’d still like to hear from you. Orca Bio is growing fast, and we’re always looking for passionate, driven people who want to help us transform the future of cell therapy at our Bay Area and Sacramento sites (and in some cases, remote/field based).
This general application is a way for you to introduce yourself to our Recruiting Team. Please submit your resume and a brief description letting us know your areas of interest and how you'd like to contribute at Orca Bio. We’ll keep your information on file and reach out if something aligns now—or in the future.
Thanks for your interest in joining the pod!
What We Offer
You may be eligible to receive pre-IPO equity, in addition to:
- Competitive medical, dental, and vision benefits
- Flexible PTO and paid holidays
- 401(k) plan
- Life and accidental death & disability coverage
- Parental leave benefits
- Free daily lunches and snacks at our on-site locations
","descriptionBodyPlain":"Didn’t find an open role that feels like the perfect fit? We’d still like to hear from you. Orca Bio is growing fast, and we’re always looking for passionate, driven people who want to help us transform the future of cell therapy at our Bay Area and Sacramento sites (and in some cases, remote/field based).\n\nThis general application is a way for you to introduce yourself to our Recruiting Team. Please submit your resume and a brief description letting us know your areas of interest and how you'd like to contribute at Orca Bio. We’ll keep your information on file and reach out if something aligns now—or in the future.\n\nThanks for your interest in joining the pod!\n\nWhat We Offer\n\nYou may be eligible to receive pre-IPO equity, in addition to:\n- Competitive medical, dental, and vision benefits\n- Flexible PTO and paid holidays\n- 401(k) plan\n- Life and accidental death & disability coverage\n- Parental leave benefits\n- Free daily lunches and snacks at our on-site locations\n","hostedUrl":"https://jobs.lever.co/orcabiosystems/5019118e-ad1b-44d3-8e1d-bfb921772b93","applyUrl":"https://jobs.lever.co/orcabiosystems/5019118e-ad1b-44d3-8e1d-bfb921772b93/apply"},{"additionalPlain":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.\n \nWho we are\n \nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.\n \nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.\n \nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.\n \nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.\n \nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.\n \nNotice to staffing firms\n \nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.\n","additional":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
\n
\nWho we are
\n
\nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\nNotice to staffing firms
\n
\nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
","categories":{"commitment":"Regular, Full-Time Employee","department":"Operations","location":"Remote","team":"Clinical Operations","allLocations":["Remote"]},"createdAt":1779486111993,"descriptionPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n\n\nSummary:\nThe Lead Clinical Data Manager will be responsible for all aspects of clinical trial data management from study start up through database lock and study close. This includes the EDC build and user acceptance testing (UAT), study data cleaning and reconciliation, query issue and resolution, and database locks. They will ensure optimized data collection, flow and access across EDC and non-EDC data sources. They are also responsible for accuracy, consistency, completeness and CDISC compliance of all clinical databases. The role will operate as a key member of the Clinical Operations team.\n","description":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
Summary:
\nThe Lead Clinical Data Manager will be responsible for all aspects of clinical trial data management from study start up through database lock and study close. This includes the EDC build and user acceptance testing (UAT), study data cleaning and reconciliation, query issue and resolution, and database locks. They will ensure optimized data collection, flow and access across EDC and non-EDC data sources. They are also responsible for accuracy, consistency, completeness and CDISC compliance of all clinical databases. The role will operate as a key member of the Clinical Operations team.
","id":"25b5f483-968c-4f28-9c88-dbb9f44f2df9","lists":[{"text":"Responsibilities","content":"\nDevelop and maintain all data management documentation, including case report forms, data management plans, edit check specifications, data review plans and data transfer agreements.\nDesign case report forms (CRFs) for electronic data capture (EDC) systems for data collection.\nPerform data entry and cleaning activities, including discrepancy management and query resolution.\nConduct data validation checks and implement quality control measures to ensure accuracy and completeness.\nCollaborate with study team members to resolve data-related issues and discrepancies.\nGenerate and review data listings, summaries and reports for data review\nServe as a primary or backup resource for issues about data management.\nEnsure compliance with guidelines, Good Clinical Practice (GCP), CDISC standards and other relevant regulations.\nContribute to the development and validation of data management software tools. \n"},{"text":"Qualifications","content":"\nBSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics or equivalent industry experience.\n5-7+ years of data management experience in the pharmaceutical or biotechnology industries, preferably in smaller biotech sponsor environment.\nStrong expertise in project/program management including stakeholder management.\nKnowledge of industry standards (CDISC, SDTM, CDASH).\nIn-depth understanding of Data Management regulatory guidelines: ICH, GCDMP, 21CFR Part 11.\nProven ability to preemptively identify data and system issues and mitigate risks to data quality.\nKnowledge and experience with development, validation, execution, maintenance, documentation, and archival of clinical data.\nExperience in development and implementation of Clinical data management standards and procedures.\nExperience with web-based EDC, clinical data management systems and medical coding dictionaries such as MedDRA and WHO Drug.\nPrior experience with Zelta by Merative (formerly IBM) CDM platform preferred.\n"}],"text":"Lead Clinical Data Manager","country":"US","workplaceType":"remote","opening":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.Summary:
\nThe Lead Clinical Data Manager will be responsible for all aspects of clinical trial data management from study start up through database lock and study close. This includes the EDC build and user acceptance testing (UAT), study data cleaning and reconciliation, query issue and resolution, and database locks. They will ensure optimized data collection, flow and access across EDC and non-EDC data sources. They are also responsible for accuracy, consistency, completeness and CDISC compliance of all clinical databases. The role will operate as a key member of the Clinical Operations team.
","descriptionBodyPlain":"Summary:\nThe Lead Clinical Data Manager will be responsible for all aspects of clinical trial data management from study start up through database lock and study close. This includes the EDC build and user acceptance testing (UAT), study data cleaning and reconciliation, query issue and resolution, and database locks. They will ensure optimized data collection, flow and access across EDC and non-EDC data sources. They are also responsible for accuracy, consistency, completeness and CDISC compliance of all clinical databases. The role will operate as a key member of the Clinical Operations team.\n","hostedUrl":"https://jobs.lever.co/orcabiosystems/25b5f483-968c-4f28-9c88-dbb9f44f2df9","applyUrl":"https://jobs.lever.co/orcabiosystems/25b5f483-968c-4f28-9c88-dbb9f44f2df9/apply"},{"additionalPlain":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.\n \nWho we are\n \nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.\n \nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.\n \nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.\n \nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.\n \nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.\n \nNotice to staffing firms\n \nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.\n","additional":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
\n
\nWho we are
\n
\nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\nNotice to staffing firms
\n
\nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
","categories":{"commitment":"Regular, Full-Time Employee","department":"General & Administrative","location":"Sacramento, CA","team":"People Operations","allLocations":["Sacramento, CA"]},"createdAt":1779985523892,"descriptionPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n \nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.\n\n\nPosition Summary: the Manager / Senior Manager, Human Resources (depending on experience) partners with leaders to operationalize People Team initiatives. Reporting into the People Partner, Manufacturing Site Operations, you will serve as the primary HR business partner to front-line and mid-level managers, providing strategic guidance, coaching, and day-to-day support to strengthen leadership capability, drive effective people management practices, support talent acquisition and career development initiatives, foster a positive and inclusive culture, ensure compliance, and promote operational excellence across manufacturing sites. \n","description":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
\n
Position Summary: the Manager / Senior Manager, Human Resources (depending on experience) partners with leaders to operationalize People Team initiatives. Reporting into the People Partner, Manufacturing Site Operations, you will serve as the primary HR business partner to front-line and mid-level managers, providing strategic guidance, coaching, and day-to-day support to strengthen leadership capability, drive effective people management practices, support talent acquisition and career development initiatives, foster a positive and inclusive culture, ensure compliance, and promote operational excellence across manufacturing sites.
\n
\n\n
Partner with front-line and mid-level managers to build leadership capabilities through coaching, training, and consultation. Represent HR in cross-functional and production meetings across Sacramento sites; provide guidance on employee and organizational matters.\nPartner closely with Talent Acquisition to support workforce planning, hiring timelines, candidate experience, and fulfillment of staffing requirements across functions and Sacramento sites.\nTrain and coach front line managers on performance management, timekeeping and attendance policies, documentation standards, and corrective action processes.\nManage and resolve complex employee relations matters, ensuring fair, consistent, and compliant application of company policies. Conduct investigations and recommend appropriate corrective actions when needed.\nSupport employee career development initiatives, leadership growth opportunities, and internal mobility programs.\nSupport implementation and optimization of HCM/HRIS systems to ensure compliance, operational efficiency, and accurate workforce management processes, including time and attendance tracking, scheduling integration , labor allocation, overtime management, meal and rest break compliance, meal waivers and shift premium administration.\nDevelop and maintain HR dashboards and reporting tools focused on labor management metrics, including attendance, absenteeism, overtime utilization, retention, turnover, and time to fill.\nPartner with People Team and cross-functional stakeholders to standardize workflows, improve system functionality, and identify opportunities to automate and streamline HR processes.\nLead and support HR on cross-functional projects such as HRIS implementations, workforce optimization projects, recognition programs, job architecture development, employee resource groups and employee engagement initiatives.\nSupport onboarding related to MasterControl JD and resume collection, eye exams, and prescription safety glasses administration.\n\n"},{"text":"Required Qualifications","content":"\n
\n- Bachelor’s degree required.
\n- 6 to 8+ years of progressive HR generalist experience with HRBP duties in life sciences, biotech and/or other highly regulated manufacturing environment, supporting a largely hourly workforce.
\n- Proactive problem-solving, time management and continuous improvement mindset.
\n- Demonstrated HRBP experience in training and coaching managers and supervisors in performance management, labor management, and time and attendance.
\n- Experience in wage and hour compliance.
\n- Experience with HCM/HRIS systems (e.g., Workday, ADP, Dayforce) particularly in time and attendance, scheduling, labor allocation, HR dashboards and reporting, performance management, document management, and learning & development.
\n- Employee relations and investigation experience.
\n- Strong interpersonal, coaching, and influencing skills with a high level of discretion and professionalism.
\n- Ability to support varying shifts as needed across multiple manufacturing sites.
\n\n
More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
","openingPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n \nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.\n","descriptionBody":"\n
Position Summary: the Manager / Senior Manager, Human Resources (depending on experience) partners with leaders to operationalize People Team initiatives. Reporting into the People Partner, Manufacturing Site Operations, you will serve as the primary HR business partner to front-line and mid-level managers, providing strategic guidance, coaching, and day-to-day support to strengthen leadership capability, drive effective people management practices, support talent acquisition and career development initiatives, foster a positive and inclusive culture, ensure compliance, and promote operational excellence across manufacturing sites.
\n
The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
\n
\nWho we are
\n
\nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\nNotice to staffing firms
\n
\nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
","categories":{"commitment":"Regular, Full-Time Employee","department":"General & Administrative","location":"Sacramento, CA","team":"People Operations","allLocations":["Sacramento, CA"]},"createdAt":1779984733249,"descriptionPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n \nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.\n\n\nPosition Summary: reporting to our Head of Talent Acquisition (TA), the Manager / Senior Manager, TA (depending on experience) will play a pivotal role in driving Orca Bio’s hiring strategies and execution, with a focus on scaling our manufacturing operations in Sacramento. Because of our rapid growth, you should be someone who thrives in a dynamic, fast-paced environment, is comfortable navigating ambiguity, and is passionate about building and improving processes with a continuous improvement mindset.\nYou will act as the TA program lead to our Sacramento site leaders and TA team —providing mentorship, driving strategic and tactical TA priorities, and serving as a go-to resource. You will lead full-cycle recruiting focused on technical, quality, and/or other production roles, directly sourcing and hiring candidates for hard-to-fill positions with minimal reliance on outside agencies. You will also work closely with our People Partner, Manufacturing Site Operations, to contribute to and provide hands-on support, bridge talent gaps, and maintain tight alignment on all facility growth strategies and people operations.\n","description":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
\n
Position Summary: reporting to our Head of Talent Acquisition (TA), the Manager / Senior Manager, TA (depending on experience) will play a pivotal role in driving Orca Bio’s hiring strategies and execution, with a focus on scaling our manufacturing operations in Sacramento. Because of our rapid growth, you should be someone who thrives in a dynamic, fast-paced environment, is comfortable navigating ambiguity, and is passionate about building and improving processes with a continuous improvement mindset.
\n
You will act as the TA program lead to our Sacramento site leaders and TA team —providing mentorship, driving strategic and tactical TA priorities, and serving as a go-to resource. You will lead full-cycle recruiting focused on technical, quality, and/or other production roles, directly sourcing and hiring candidates for hard-to-fill positions with minimal reliance on outside agencies. You will also work closely with our People Partner, Manufacturing Site Operations, to contribute to and provide hands-on support, bridge talent gaps, and maintain tight alignment on all facility growth strategies and people operations.
\n
\n\n
Proactively partners with the People Partner, Manufacturing Site Operations and functional leadership teams to implement and execute compliant, scalable TA hiring and operations.\nNavigates ambiguous, rapidly growing environments with an entrepreneurial spirit, translating high-level talent acquisition needs into structured execution with clear, measurable goals.\nActs as the program lead and mentor for a team of contract recruiters, guiding talent discovery strategies, oversight of day-to-day sourcing efforts, and enhancing TA operational workflows in a fast-paced environment.\nDirectly own full-lifecycle recruitment of professional, technical, and leadership positions to support the rapid expansion of the functional business.\nOwns the end-to-end offer process, including structuring complex compensation packages, calculating equity/stock options, and leading competitive offer negotiations to successfully close top talent.\nStrengthens employer branding and drives localized talent pipelines and outreach initiatives, including Early Talent programs, university partnerships, and regional career fairs.\nCultivates a best-in-class candidate and hiring manager experience, demonstrating excellent communication, negotiation, and problem-solving skills to ensure continued respect and cooperation among cross-functional teams.\nPartners with People team on the modernization, implementation, and ongoing management of our job descriptions.\nSupports the continuous optimization and team navigation of Applicant Tracking System (Lever) and HRIS systems to streamline and scale the recruiting function.\n\n"},{"text":"Required Qualifications","content":"\n\n
Bachelor's degree.\n6 to 8+ years of talent acquisition experience within biotech/life sciences, ideally with a combination of agency and in-house experience.\nExtensive experience sourcing and recruiting within technical operations, manufacturing facilities, and supply chain environments, as well as other related functional domains.\nExperience with non-exempt and shift-environment logistics, with hands-on experience navigating time-and-attendance practices and hourly compliance rules.\nTrack record of success operating within a fast-paced, small-company environment preferred, demonstrating high comfort with ambiguity and the capability to execute effectively in a rapidly growing company.\nExperience serving as a people/program manager preferred, with a hands-on approach to identifying solutions; strong problem-solving skills and sound judgement across sensitive areas.\nProficiency with modern ATS platforms and sourcing platforms; systems and process oriented.\nTech-forward and adaptable mindset; possesses an \"AI-ready\" aptitude to learn, adopt, and integrate modern AI-enabled talent tools.\nExcellent written and verbal communication, time management and organizational skills, including presentation ability and with Microsoft Excel.\n\n"}],"salaryRange":{"min":125000,"max":150000,"currency":"USD","interval":"per-year-salary"},"text":"Manager / Senior Manager, Talent Acquisition","country":"US","workplaceType":"onsite","opening":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
","openingPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n \nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.\n","descriptionBody":"\n
Position Summary: reporting to our Head of Talent Acquisition (TA), the Manager / Senior Manager, TA (depending on experience) will play a pivotal role in driving Orca Bio’s hiring strategies and execution, with a focus on scaling our manufacturing operations in Sacramento. Because of our rapid growth, you should be someone who thrives in a dynamic, fast-paced environment, is comfortable navigating ambiguity, and is passionate about building and improving processes with a continuous improvement mindset.
\n
You will act as the TA program lead to our Sacramento site leaders and TA team —providing mentorship, driving strategic and tactical TA priorities, and serving as a go-to resource. You will lead full-cycle recruiting focused on technical, quality, and/or other production roles, directly sourcing and hiring candidates for hard-to-fill positions with minimal reliance on outside agencies. You will also work closely with our People Partner, Manufacturing Site Operations, to contribute to and provide hands-on support, bridge talent gaps, and maintain tight alignment on all facility growth strategies and people operations.
\n
The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
\n
\nWho we are
\n
\nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\nNotice to staffing firms
\n
\nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
","categories":{"commitment":"Regular, Full-Time Employee","department":"General & Administrative","location":"Menlo Park, CA","team":"Accounting","allLocations":["Menlo Park, CA"]},"createdAt":1778789310607,"descriptionPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n\n\nAsManager, Accounting you will oversee the daily operations of the company’s accounting function, ensuring accurate, timely, and compliant financial reporting and accounting operations in a fast-paced, high-growth environment. You will lead and develop the accounting team, manage high-volume transactional processes and month-end close activities, maintain strong internal controls, and partner cross-functionally to support the company’s continued growth and operational execution.\n","description":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
As Manager, Accounting you will oversee the daily operations of the company’s accounting function, ensuring accurate, timely, and compliant financial reporting and accounting operations in a fast-paced, high-growth environment. You will lead and develop the accounting team, manage high-volume transactional processes and month-end close activities, maintain strong internal controls, and partner cross-functionally to support the company’s continued growth and operational execution.
","id":"a0f3c73d-abb3-445c-ba39-8cfb9530ded6","lists":[{"text":"Essential Duties & Key Responsibilities","content":"\nOversee all aspects of the accounting function, ensuring accurate, timely, and compliant financial reporting while supporting the organization’s strategic and operational objectives.\nManage and maintain the general ledger, including preparing and reviewing journal entries within assigned areas of responsibility.\nDevelop and maintain a comprehensive understanding of the company’s financial reporting processes and general ledger structure.\nEnsure compliance with internal accounting policies, procedures, GAAP standards, and applicable regulatory requirements.\nLead, mentor, and supervise accounting staff, while driving improvements and enhancing operational efficiency.\nCoordinate and support external audit activities, including annual financial statement audits, quarterly reviews, and internal control testing.\nOversee statutory and regulatory filings in accordance with local jurisdiction requirements, including but not limited to 1099 reporting, sales and use tax, property tax, and census reporting.\nExperience with clinical trial accounting and accrual management is preferred but not required.\nProficiency with ERP systems, preferably NetSuite and strong knowledge of accounting software and financial reporting tools.\n"},{"text":"Minimum Experience, Education, Certifications, Licenses","content":"\nBachelor’s degree in Accounting, Finance, or related field; CPA preferred.\n5+ years of progressive accounting experience within biotechnology or life sciences.\nPrior people management experience required, including leading and developing accounting staff and driving accountability/performance.\nStrong knowledge of day-to-day accounting operations, including accounts payable, general ledger, monthly close, accruals, and statutory/compliance filings.\nExperience managing high-volume AP and operational accounting workflows in a fast-paced environment.\nDemonstrated ability to operate with firmness and accountability while building effective cross-functional relationships.\nStrong organizational skills, attention to detail, and ability to prioritize across competing deadlines.\nExperience with ERP/accounting systems and Microsoft Excel.\n"}],"salaryRange":{"min":125000,"max":155000,"currency":"USD","interval":"per-year-salary"},"text":"Manager, Accounting","country":"US","workplaceType":"onsite","opening":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.As Manager, Accounting you will oversee the daily operations of the company’s accounting function, ensuring accurate, timely, and compliant financial reporting and accounting operations in a fast-paced, high-growth environment. You will lead and develop the accounting team, manage high-volume transactional processes and month-end close activities, maintain strong internal controls, and partner cross-functionally to support the company’s continued growth and operational execution.
","descriptionBodyPlain":"AsManager, Accounting you will oversee the daily operations of the company’s accounting function, ensuring accurate, timely, and compliant financial reporting and accounting operations in a fast-paced, high-growth environment. You will lead and develop the accounting team, manage high-volume transactional processes and month-end close activities, maintain strong internal controls, and partner cross-functionally to support the company’s continued growth and operational execution.\n","hostedUrl":"https://jobs.lever.co/orcabiosystems/a0f3c73d-abb3-445c-ba39-8cfb9530ded6","applyUrl":"https://jobs.lever.co/orcabiosystems/a0f3c73d-abb3-445c-ba39-8cfb9530ded6/apply"},{"additionalPlain":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.\n \nWho we are\n \nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.\n \nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.\n \nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.\n \nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.\n \nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.\n \nNotice to staffing firms\n \nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.\n","additional":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
\n
\nWho we are
\n
\nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\nNotice to staffing firms
\n
\nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
","categories":{"commitment":"Regular, Full-Time Employee","department":"Operations","location":"Sacramento, CA","team":"Facilities","allLocations":["Sacramento, CA"]},"createdAt":1773419447173,"descriptionPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n\n\nThe Manager,Facilities is responsible for overseeing and maintaining the physical tenant infrastructure, coordinating and executing maintenance and calibration/certification activities, operating utility systems, managing service providers, maintaining GMP and safety compliance, and serving as the liaison with the building landlord. They will work closely with other departments to support the overall goals of the organization, including managing facilities programs, services and activities. \n \n \nThis will be an onsite role at our clinical manufacturing facility (3400 Business Drive) with a schedule of Monday - Friday (7 a.m. / 8 a.m. to 4 p.m. / 5 p.m.).\n","description":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
The
Manager, Facilities is responsible for overseeing and maintaining the physical tenant infrastructure, coordinating and executing maintenance and calibration/certification activities, operating utility systems, managing service providers, maintaining GMP and safety compliance, and serving as the liaison with the building landlord. They will work closely with other departments to support the overall goals of the organization, including managing facilities programs, services and activities.\n
\n
\nThis will be an onsite role at our clinical manufacturing facility (3400 Business Drive) with a schedule of Monday - Friday (7 a.m. / 8 a.m. to 4 p.m. / 5 p.m.).
","id":"c46c3777-4f79-43b4-adb6-c265026a5b24","lists":[{"text":"Key Responsibilities:","content":"Facility Operations & Maintenance:
\n\n\n
\nOversee the day-to-day operations and maintenance of the facility, ensuring all systems are functioning properly (HVAC, electrical, plumbing, security, etc.).
\n\n\n\n
\nDevelop, implement and manage preventive maintenance and calibration programs to ensure the facility is GMP compliant.
\n\n
\nCollaborate with Facilities and Production Planning to schedule and coordinate repairs and maintenance activities for building systems and equipment.
\n\n
\nEnsure accurate record-keeping for facility operations, and equipment maintenance, including Computerize Maintenance Management System (CMMS) and logbooks.
\n\n
\nManage vendor relationships for services such as cleaning, pest control, maintenance and calibration services, ensuring delivery of quality services and compliance with service agreements.
\n\n
\nReview and approve vendor service documentation
\n\n
\nRespond to facility-related requests, BMS and FMS alarms, and emergent issues
\n\n
\nComplete quarterly trend reviews for alarm management and pest control programs.
\n\n\n
Health, Safety & Compliance:
\n
\n\n
\nEnsure the facility complies with all relevant safety, environmental, and regulatory requirements (e.g., OSHA, GMP, FDA, local building codes).
\n\n
\nParticipate in regular inspections to identify and mitigate risks related to safety, health, and environmental impacts.
\n\n\n
Budget Management:
\n
\n\n
Support development and management of the facility’s operational and maintenance budget, controlling costs related to maintenance, repairs and outside services.\n\n
\n
Project Management:
\n\n
\nPlan and coordinate facility-related projects such as improvements and space planning.
\n\n
\nManage projects related to the installation of new equipment.
\n\n
\nWork with other departments, external contractors and vendors to ensure successful project execution.
\n\n\n
\n
\n
\n
Education:
\n\n\n
Associate’s or Bachelor’s degree in Facility Management, Engineering, or a related field preferred. \n\n
Experience:
\n
\n\n
5 years of experience in facility management in a GMP environment, preferably in the cell therapy, biotechnology or pharmaceutical manufacturing facility.\n\n
Skills:
\n
\n\n
\nStrong knowledge of building systems (HVAC, electrical, plumbing), maintenance and calibration programs, GMP regulatory standards, and safety requirements in the biopharmaceutical/cell therapy industry.
\n\n
\nExcellent leadership, communication, and interpersonal skills.
\n\n
\nExperience/proficiency with maintenance management software and systems.
\n\n
\nExcellent project and time management skills with the ability to oversee multiple tasks at once.
\n\n
\nStrong problem-solving and troubleshooting, and ability to make sound decisions.
\n\n\n
\n
\n
\n\n
\nThe position requires on-site presence and typically involves regular office hours but may require on-call availability and after-hours presence for planned or unplanned work, or emergency response.
\n\n
\nGowning for cleanroom access.
\n\n\n
More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.The
Manager, Facilities is responsible for overseeing and maintaining the physical tenant infrastructure, coordinating and executing maintenance and calibration/certification activities, operating utility systems, managing service providers, maintaining GMP and safety compliance, and serving as the liaison with the building landlord. They will work closely with other departments to support the overall goals of the organization, including managing facilities programs, services and activities.\n
\n
\nThis will be an onsite role at our clinical manufacturing facility (3400 Business Drive) with a schedule of Monday - Friday (7 a.m. / 8 a.m. to 4 p.m. / 5 p.m.).
","descriptionBodyPlain":"The Manager,Facilities is responsible for overseeing and maintaining the physical tenant infrastructure, coordinating and executing maintenance and calibration/certification activities, operating utility systems, managing service providers, maintaining GMP and safety compliance, and serving as the liaison with the building landlord. They will work closely with other departments to support the overall goals of the organization, including managing facilities programs, services and activities. \n \n \nThis will be an onsite role at our clinical manufacturing facility (3400 Business Drive) with a schedule of Monday - Friday (7 a.m. / 8 a.m. to 4 p.m. / 5 p.m.).\n","hostedUrl":"https://jobs.lever.co/orcabiosystems/c46c3777-4f79-43b4-adb6-c265026a5b24","applyUrl":"https://jobs.lever.co/orcabiosystems/c46c3777-4f79-43b4-adb6-c265026a5b24/apply"},{"additionalPlain":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.\n \nWho we are\n \nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.\n \nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.\n \nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.\n \nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.\n \nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.\n \nNotice to staffing firms\n \nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.\n","additional":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
\n
\nWho we are
\n
\nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\nNotice to staffing firms
\n
\nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
","categories":{"commitment":"Regular, Full-Time Employee","department":"Engineering","location":"Sacramento, CA","team":"MSAT","allLocations":["Sacramento, CA"]},"createdAt":1773172504348,"descriptionPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n \nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.\n\n\nThe Manager, Manufacturing Science and Technology (MSAT) is responsible for leading Manufacturing Science and Technology process engineers, across several shifts, within the commercial manufacturing site. This role oversees the day-to-day MSAT operations to support clinical and commercial production, deviations, product impact assessments, change controls, CAPAs, risk assessment, tech transfer and continuous improvement of manufacturing processes and technologies to ensure product quality, efficiency and compliance with regulatory standards.\n","description":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
The Manager, Manufacturing Science and Technology (MSAT) is responsible for leading Manufacturing Science and Technology process engineers, across several shifts, within the commercial manufacturing site. This role oversees the day-to-day MSAT operations to support clinical and commercial production, deviations, product impact assessments, change controls, CAPAs, risk assessment, tech transfer and continuous improvement of manufacturing processes and technologies to ensure product quality, efficiency and compliance with regulatory standards.
","id":"92a688a8-448e-4d09-ab3f-7590aa21973d","lists":[{"text":"Physical Demands","content":"\nProduction Associate Roles: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.\nMost roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.\n"},{"text":"Work Conditions","content":"\nMany roles must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video-based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs.\n"},{"text":"Essential Duties & Key Responsibilities:","content":"\nLead a small team of engineers and technical experts \nProvide leadership and guidance in technical decision-making related to manufacturing operations \nManage review and approval of quality records owned or supported by MSAT\nImplement process improvements based on data analysis and scientific principles \nLead efforts in production excellence to support commercial scalability and compliance \nSupport the transfer of processes from R&D into GMP manufacturing facilities \nCollaborate with cross functional teams to trouble shoot and resolve technical issues \n"},{"text":"Minimum Qualifications:","content":"\nB.S. in Engineering, Chemistry, Pharmacy or related scientific discipline required\n6+ years of industry experience with manufacturing processes and equipment in related fields: biologics, pharmaceutical fill and finish or drug substance manufacturing, Chemical or food industries\n3+ years of people leadership experience\nPrior experience in regulated, GMP manufacturing operations\nStrong communication and problem-solving skills\n"},{"text":"Preferred Qualifications:","content":"\nMasters or PhD in Chemical Engineering, Biochemistry or Biology is preferred\n2 to 4 years of leadership experience preferred\nExperience in Cell therapy manufacturing preferred\n"}],"salaryRange":{"min":115000,"max":145000,"currency":"USD","interval":"per-year-salary"},"text":"Manager, Manufacturing Sciences & Technology (MSAT)","country":"US","workplaceType":"onsite","opening":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
","openingPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n \nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.\n","descriptionBody":"The Manager, Manufacturing Science and Technology (MSAT) is responsible for leading Manufacturing Science and Technology process engineers, across several shifts, within the commercial manufacturing site. This role oversees the day-to-day MSAT operations to support clinical and commercial production, deviations, product impact assessments, change controls, CAPAs, risk assessment, tech transfer and continuous improvement of manufacturing processes and technologies to ensure product quality, efficiency and compliance with regulatory standards.
","descriptionBodyPlain":"The Manager, Manufacturing Science and Technology (MSAT) is responsible for leading Manufacturing Science and Technology process engineers, across several shifts, within the commercial manufacturing site. This role oversees the day-to-day MSAT operations to support clinical and commercial production, deviations, product impact assessments, change controls, CAPAs, risk assessment, tech transfer and continuous improvement of manufacturing processes and technologies to ensure product quality, efficiency and compliance with regulatory standards.\n","hostedUrl":"https://jobs.lever.co/orcabiosystems/92a688a8-448e-4d09-ab3f-7590aa21973d","applyUrl":"https://jobs.lever.co/orcabiosystems/92a688a8-448e-4d09-ab3f-7590aa21973d/apply"},{"additionalPlain":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. \n \nWho we are\n \nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.\n \nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.\n \nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.\n \nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.\n \nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.\n \nNotice to staffing firms\n \nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.\n","additional":"\n
The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits.
\n
\n
Who we are
\n
\n
We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\n
We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\n
We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\n
We maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\n
We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\n
Notice to staffing firms
\n
\n
Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
\n
\n
More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\n
\n
We are establishing manufacturing operations on the East Coast to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
\n
\n\n
The Manufacturing Process Lead conducts cGMP manufacturing activities to produce clinical and commercial cell therapies and helps to optimize Manufacturing processes. The Lead ensures and adheres to quality standards, regulatory requirements and aseptic production techniques. This position involves repeatedly executing manufacturing processes, cleaning and maintaining production equipment and workstations and documenting production activities in a highly regulated environment. This position also entails on-shift oversight of production activities to ensure timely, efficient, and quality-driven execution of each day’s objectives.
\n
This is a shift-based position, Mon – Fri, day shift (1st shift)
\n
\n\n
Production Associate Roles: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.\nMost roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.\n\n"}],"salaryRange":{"currency":"USD","interval":"per-year-salary","min":70000,"max":90000},"text":"Manufacturing Process Lead","country":"US","workplaceType":"onsite","opening":"","openingPlain":"","descriptionBody":"\n
More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\n
\n
We are establishing manufacturing operations on the East Coast to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
\n
\n\n
The Manufacturing Process Lead conducts cGMP manufacturing activities to produce clinical and commercial cell therapies and helps to optimize Manufacturing processes. The Lead ensures and adheres to quality standards, regulatory requirements and aseptic production techniques. This position involves repeatedly executing manufacturing processes, cleaning and maintaining production equipment and workstations and documenting production activities in a highly regulated environment. This position also entails on-shift oversight of production activities to ensure timely, efficient, and quality-driven execution of each day’s objectives.
\n
This is a shift-based position, Mon – Fri, day shift (1st shift)
\n
\n
The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits.
\n
\n
Who we are
\n
\n
We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\n
We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\n
We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\n
We maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\n
We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\n
Notice to staffing firms
\n
\n
Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
\n
\n
More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\n
\n
We are establishing manufacturing operations on the East Coast to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
\n
\nThe MSAT Process Engineer works to improve the efficiency and safety of the drug product manufacturing process. This role is responsible for life cycle management of clinical and commercial products including process monitoring and troubleshooting, implementation and validation of process improvements and changes, and supporting investigations and corrective/preventive actions.
","id":"be3140a1-a9de-458a-8c95-5b8f80e6fc0b","lists":[{"text":"Essential Duties & Key Responsibilities:","content":"\n\n
Performs ongoing monitoring of existing products and processes\nGenerate metrics and reports for process monitoring and continuous process verification\nSupport process improvements and changes including electronic batch record creation and modifications\nInvestigates process events and implements corrective and preventive actions\nProvides troubleshooting support for manufacturing events, equipment performance and material issues\nPerforms root cause analysis to isolate cause of events and determine appropriate corrective actions\nAuthors, executes and owns change controls, technical protocols, reports and activities to support improvements\nWrites and ensure proper execution of validation protocols and testing in line with required life cycle management activities\n\n"},{"text":"Minimum Qualifications:","content":"\nB.S. in Engineering or similar fields\n3+ years of experience with manufacturing processes and equipment in related fields: biologics, pharmaceutical fill and finish or drug substance manufacturing, Chemical or food industries\nPrior experience in regulated, GMP manufacturing operations\nExperience in biotechnology and cell therapy manufacturing preferred\nStrong communication and problem solving skills, with a desire to improve upon established processes\nFlexibility to work outside standard business hours when needed to support site priorities, deadlines, or critical business needs.\n"},{"text":"Physical Demands","content":"\n\n
Production Associate Roles: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.\nMost roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.\n\n"}],"salaryRange":{"currency":"USD","interval":"per-year-salary","min":80000,"max":100000},"text":"Manufacturing Sciences and Technology (MSAT) Process Engineer","country":"US","workplaceType":"onsite","opening":"","openingPlain":"","descriptionBody":"\n
More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\n
\n
We are establishing manufacturing operations on the East Coast to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
\n
\nThe MSAT Process Engineer works to improve the efficiency and safety of the drug product manufacturing process. This role is responsible for life cycle management of clinical and commercial products including process monitoring and troubleshooting, implementation and validation of process improvements and changes, and supporting investigations and corrective/preventive actions.
","descriptionBodyPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n \nWe are establishing manufacturing operations on the East Coast to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.\n \nThe MSAT Process Engineer works to improve the efficiency and safety of the drug product manufacturing process. This role is responsible for life cycle management of clinical and commercial products including process monitoring and troubleshooting, implementation and validation of process improvements and changes, and supporting investigations and corrective/preventive actions. \n","hostedUrl":"https://jobs.lever.co/orcabiosystems/be3140a1-a9de-458a-8c95-5b8f80e6fc0b","applyUrl":"https://jobs.lever.co/orcabiosystems/be3140a1-a9de-458a-8c95-5b8f80e6fc0b/apply"},{"additionalPlain":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.\n \nWho we are\n \nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.\n \nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.\n \nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.\n \nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.\n \nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.\n \nNotice to staffing firms\n \nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.\n","additional":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
\n
\nWho we are
\n
\nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\nNotice to staffing firms
\n
\nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
","categories":{"commitment":"Regular, Full-Time Employee","department":"Manufacturing","location":"Sacramento, CA","team":"Production","allLocations":["Sacramento, CA"]},"createdAt":1773244705766,"descriptionPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n\n\nThe Material Handler - Day Shift ensures the efficient handling, storage and distribution of pharmaceutical materials and products for Orca’s cell therapy products, ensuring adherence to strict quality standards and regulatory requirements. This position involves executing processes related to warehouse materials and inventory, kitting materials for production use and managing the movement, intake and shipping of drug products and samples.\n \nDay Shift Hours Worked:\n• 6:00am to 6:30pm or\n• 6:30am to 7:00pm\n \nWork Week Schedule:\n• Sunday, Monday, Tuesday + every other Wednesday or\n• Thursday, Friday, Saturday + every other Wednesday\n","description":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
The Material Handler - Day Shift ensures the efficient handling, storage and distribution of pharmaceutical materials and products for Orca’s cell therapy products, ensuring adherence to strict quality standards and regulatory requirements. This position involves executing processes related to warehouse materials and inventory, kitting materials for production use and managing the movement, intake and shipping of drug products and samples.
\n
\nDay Shift Hours Worked:
\n• 6:00am to 6:30pm or
\n• 6:30am to 7:00pm
\n
\nWork Week Schedule:
\n• Sunday, Monday, Tuesday + every other Wednesday or
\n• Thursday, Friday, Saturday + every other Wednesday
","id":"aea5add3-e338-4a22-a652-c5ff9f269998","lists":[{"text":"Physical Demands:","content":"\nProduction Associate Roles: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.\nMust be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.\n"},{"text":"Work Conditions:","content":"\nMust be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.\nMust be comfortable regularly participating in video-based meetings.\nMay be required to work scheduled overtime, weekends, or holidays based on business needs.\n"},{"text":"Essential Duties & Key Responsibilities:","content":"\nReceive, inspect and verify incoming materials against orders and documentation \nEnsure materials are moved and stored in their correct locations \nMaintain accurate inventory records, perform cycle counts, and manage material expiration \nPrepare consumable materials kits for use in production \nMovement and transfer of materials including drug products and samples from production \nMaintenance of consumable gowning stock across various facility locations \nReceipt and incoming donor cells and shipment of patient drug productions \nExecution of cold storage practices and cryopreservation of drug products when needed \n"},{"text":"Minimum Experience, Education, Certifications, Licenses:","content":"\nMinimum of high school diploma or GED \nA.S. degree is preferred, but not required \nExperience with material management systems \nExperience in warehouse operations and material movements \nCell and gene therapy knowledge is beneficial \n"},{"text":"Personal Qualities:","content":"\nAbility to gown and work in clean rooms areas \nDemonstrates strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment \nStrong interpersonal skills and ability to communicate effectively \nAbility to work in a collaborative manner \nAbility to work independently and as part of a team \nHighly tolerant and respectful of all team members \nA sense of humor is always appreciated \nStrong problem-solving skills \nFollow cleanroom protocols, e.g. no cosmetics including make-up, painted nails, jewelry or piercings, and must disclose any shedding skin condition \nOccasional need to ascend/descend stairs within work space; job requires standing/walking \nAbility to lift up to 50 lbs. \n"}],"salaryRange":{"min":23,"max":26,"currency":"USD","interval":"per-hour-wage"},"text":"Material Handler - Day Shift","country":"US","workplaceType":"onsite","opening":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.The Material Handler - Day Shift ensures the efficient handling, storage and distribution of pharmaceutical materials and products for Orca’s cell therapy products, ensuring adherence to strict quality standards and regulatory requirements. This position involves executing processes related to warehouse materials and inventory, kitting materials for production use and managing the movement, intake and shipping of drug products and samples.
\n
\nDay Shift Hours Worked:
\n• 6:00am to 6:30pm or
\n• 6:30am to 7:00pm
\n
\nWork Week Schedule:
\n• Sunday, Monday, Tuesday + every other Wednesday or
\n• Thursday, Friday, Saturday + every other Wednesday
","descriptionBodyPlain":"The Material Handler - Day Shift ensures the efficient handling, storage and distribution of pharmaceutical materials and products for Orca’s cell therapy products, ensuring adherence to strict quality standards and regulatory requirements. This position involves executing processes related to warehouse materials and inventory, kitting materials for production use and managing the movement, intake and shipping of drug products and samples.\n \nDay Shift Hours Worked:\n• 6:00am to 6:30pm or\n• 6:30am to 7:00pm\n \nWork Week Schedule:\n• Sunday, Monday, Tuesday + every other Wednesday or\n• Thursday, Friday, Saturday + every other Wednesday\n","hostedUrl":"https://jobs.lever.co/orcabiosystems/aea5add3-e338-4a22-a652-c5ff9f269998","applyUrl":"https://jobs.lever.co/orcabiosystems/aea5add3-e338-4a22-a652-c5ff9f269998/apply"},{"additionalPlain":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.\n \nWho we are\n \nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.\n \nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.\n \nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.\n \nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.\n \nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.\n \nNotice to staffing firms\n \nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.\n","additional":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
\n
\nWho we are
\n
\nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\nNotice to staffing firms
\n
\nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
","categories":{"commitment":"Regular, Full-Time Employee","department":"Commercial","location":"Remote","team":"Sales","allLocations":["Remote"]},"createdAt":1780012098238,"descriptionPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n\n\nPosition Summary: The Orca-T Account Manager(Associate Director level) will serve as the primary liaison between Orca Bio and our Authorized Treatment Centers (ATCs). This individual is responsible for building and managing key relationships, supporting treatment site readiness and execution, and driving appropriate use of Orca Bio’s approved therapies. The OTAM plays a central role in creating a smooth and effective experience for treatment sites, physicians, and other healthcare stakeholders. This is a high-impact, field-based role that requires both strategic thinking and tactical execution. It offers the opportunity to help shape how groundbreaking therapies are delivered to patients who need them most.\n \nTravel/Location: Must live in assigned territory (recruiting for multiple territories). Willingness to travel up to 50%, based on business needs.\n","description":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
Position Summary: The Orca-T Account Manager (Associate Director level) will serve as the primary liaison between Orca Bio and our Authorized Treatment Centers (ATCs). This individual is responsible for building and managing key relationships, supporting treatment site readiness and execution, and driving appropriate use of Orca Bio’s approved therapies. The OTAM plays a central role in creating a smooth and effective experience for treatment sites, physicians, and other healthcare stakeholders. This is a high-impact, field-based role that requires both strategic thinking and tactical execution. It offers the opportunity to help shape how groundbreaking therapies are delivered to patients who need them most.
\n
\n\n
\n
Travel/Location: Must live in assigned territory (recruiting for multiple territories). Willingness to travel up to 50%, based on business needs.
\n
\n
Build and Strengthen ATC Relationships:
• Serve as the primary point of contact for assigned ATCs.
• Develop deep, trusted relationships with decision-makers and stakeholders (including clinicians, operational leads, and executives).
• Maintain detailed account profiles and insight-driven strategic plans for each site.
\n
Coordinate ATC Operations:
• Lead site targeting activities including identification, qualification, and confirmation to become an ATC.
• Serve as the on-the-ground expert for logistics and operational readiness, from patient referral through product administration.
• Oversee activities related to product handling, including Chain of Identity (COI) and Chain of Custody (COC) compliance.
\n
Support Clinical and Commercial Engagement:
• Educate site personnel on Orca Bio’s approved therapies, relevant clinical data, and patient eligibility pathways.
• Work closely with cross-functional teams (Activation Manager, Medical Affairs, Clinical Operations, Market Access, Quality, Marketing) to support ATC needs and resolve barriers to treatment.
• Facilitate communication of the latest scientific and operational updates to ATCs.
\n
\nDrive Utilization and Insights:
\n• Analyze account performance and proactively identify opportunities to optimize site engagement and therapy utilization.
• Gather and share key market insights and feedback from ATCs with internal stakeholders to help inform strategy and operations.
• Represent Orca Bio at key conferences and professional meetings as needed.
"},{"text":"Qualifications","content":"Required:
\n• Bachelor’s degree (BA/BS) required; advanced degree in a scientific or business field preferred.
• Minimum 8-10 years of experience in healthcare, biotech, or pharmaceutical environment, preferably in cell therapy.
• Proven track record in account management, preferably in oncology, hematology, or cell therapy.
• Strong operational understanding of academic medical centers and/or BMT transplant centers.
\n
\nPreferred:
\n• MBA or related advanced degree.
• 5+ years of relevant experience in hematology/oncology or bone marrow transplantation, preferably in account management.
• Previous experience launching or supporting cell or gene therapy products.
• Familiarity with site operations, patient access pathways, and clinical treatment logistics.
• Prior experience working in cross-functional field-based teams.
"}],"text":"Orca-T Account Manager","country":"US","workplaceType":"remote","opening":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.Position Summary: The Orca-T Account Manager (Associate Director level) will serve as the primary liaison between Orca Bio and our Authorized Treatment Centers (ATCs). This individual is responsible for building and managing key relationships, supporting treatment site readiness and execution, and driving appropriate use of Orca Bio’s approved therapies. The OTAM plays a central role in creating a smooth and effective experience for treatment sites, physicians, and other healthcare stakeholders. This is a high-impact, field-based role that requires both strategic thinking and tactical execution. It offers the opportunity to help shape how groundbreaking therapies are delivered to patients who need them most.
\n
\n\n
\n
Travel/Location: Must live in assigned territory (recruiting for multiple territories). Willingness to travel up to 50%, based on business needs.
\n
\n
The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
\n
\nWho we are
\n
\nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\nNotice to staffing firms
\n
\nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
","categories":{"commitment":"Regular, Full-Time Employee","department":"Commercial","location":"Remote","team":"Launch Operations & Enablement","allLocations":["Remote"]},"createdAt":1780011899380,"descriptionPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n\n\nPosition Summary: The Orca-T Activation Manager(Associate Director level) will serve as the primary liaison between Orca Bio and identified hospitals becoming Authorized Treatment Centers (ATCs). This individual is responsible for building and managing key relationships, supporting site readiness and execution, and driving appropriate use of Orca Bio’s investigational therapies. Reporting into the VP of Account Management and Site Enablement, the Activation Manager plays a central role in creating a smooth and effective onboarding experience for treatment sites, physicians, and other healthcare stakeholders. This is a high-impact, field-based role that requires both strategic thinking and tactical execution. It offers the opportunity to help shape how groundbreaking therapies are delivered to patients who need them most.\n \nTravel/Location: Must live in assigned territory (recruiting for multiple territories). Willingness to travel up to 50%, based on business needs.\n","description":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
Position Summary: The Orca-T Activation Manager (Associate Director level) will serve as the primary liaison between Orca Bio and identified hospitals becoming Authorized Treatment Centers (ATCs). This individual is responsible for building and managing key relationships, supporting site readiness and execution, and driving appropriate use of Orca Bio’s investigational therapies. Reporting into the VP of Account Management and Site Enablement, the Activation Manager plays a central role in creating a smooth and effective onboarding experience for treatment sites, physicians, and other healthcare stakeholders. This is a high-impact, field-based role that requires both strategic thinking and tactical execution. It offers the opportunity to help shape how groundbreaking therapies are delivered to patients who need them most.
\n
\nTravel/Location: Must live in assigned territory (recruiting for multiple territories). Willingness to travel up to 50%, based on business needs.
","id":"d7cdbd56-a470-4618-a063-8c57d25ebf6d","lists":[{"text":"Key Responsibilities","content":"Build and Strengthen ATC Relationships:
• Serve as the primary point of contact for onboarding ATCs.
• Develop deep, trusted relationships with decision-makers and stakeholders (including clinicians, operational leads, and executives).
• Maintain detailed account profiles and capture insights for each site.
\n
Coordinate ATC Operations:
• Lead site onboarding activities including qualification, training, and workflow setup.
• Serve as the on-the-ground expert for feasibility of Orca logistics and operational readiness from Donor Collection to Product infusion.
• Oversee training activities related to product handling, including Chain of Identity (COI) and Chain of Custody (COC) compliance.
\n
Support Clinical and Commercial Engagement:
• Work closely with cross-functional teams (Account Managers, Medical Affairs, Clinical Operations, Market Access, Quality, Marketing) to support ATC needs and resolve barriers to treatment.
• Facilitate communication of the latest operational updates to ATCs.
Streamline and Expedite time to Onboard and Activate ATCs:
• Analyze onboarding activities and timelines to proactively identify opportunities to optimize site onboarding and activation.
• Gather and share key ATC insights and feedback from ATCs with internal stakeholders to help inform strategy and operations.
• Represent Orca Bio at key conferences and professional meetings as needed.
"},{"text":"Qualifications","content":"Required:
\n• Bachelor’s degree (BA/BS) required; advanced degree in a scientific or business field preferred.
• Minimum 8-10 years of experience in healthcare, biotech, or pharmaceutical environment, preferably in cell therapy.
• Proven track record in account management, preferably in oncology, hematology, or cell therapy.
• Strong operational understanding of academic medical centers and/or BMT transplant centers.
\n
\nPreferred:
\n• MBA or related advanced degree.
• 5+ years of experience in hematology/oncology or bone marrow transplantation.
• Previous experience launching or supporting cell or gene therapy products.
• Familiarity with site operations, patient access pathways, and clinical treatment logistics.
• Prior experience working in cross-functional field-based teams.
"}],"text":"Orca-T Activation Manager","country":"US","workplaceType":"remote","opening":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.Position Summary: The Orca-T Activation Manager (Associate Director level) will serve as the primary liaison between Orca Bio and identified hospitals becoming Authorized Treatment Centers (ATCs). This individual is responsible for building and managing key relationships, supporting site readiness and execution, and driving appropriate use of Orca Bio’s investigational therapies. Reporting into the VP of Account Management and Site Enablement, the Activation Manager plays a central role in creating a smooth and effective onboarding experience for treatment sites, physicians, and other healthcare stakeholders. This is a high-impact, field-based role that requires both strategic thinking and tactical execution. It offers the opportunity to help shape how groundbreaking therapies are delivered to patients who need them most.
\n
\nTravel/Location: Must live in assigned territory (recruiting for multiple territories). Willingness to travel up to 50%, based on business needs.
","descriptionBodyPlain":"Position Summary: The Orca-T Activation Manager(Associate Director level) will serve as the primary liaison between Orca Bio and identified hospitals becoming Authorized Treatment Centers (ATCs). This individual is responsible for building and managing key relationships, supporting site readiness and execution, and driving appropriate use of Orca Bio’s investigational therapies. Reporting into the VP of Account Management and Site Enablement, the Activation Manager plays a central role in creating a smooth and effective onboarding experience for treatment sites, physicians, and other healthcare stakeholders. This is a high-impact, field-based role that requires both strategic thinking and tactical execution. It offers the opportunity to help shape how groundbreaking therapies are delivered to patients who need them most.\n \nTravel/Location: Must live in assigned territory (recruiting for multiple territories). Willingness to travel up to 50%, based on business needs.\n","hostedUrl":"https://jobs.lever.co/orcabiosystems/d7cdbd56-a470-4618-a063-8c57d25ebf6d","applyUrl":"https://jobs.lever.co/orcabiosystems/d7cdbd56-a470-4618-a063-8c57d25ebf6d/apply"},{"additionalPlain":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.\n \nWho we are\n \nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.\n \nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.\n \nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.\n \nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.\n \nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.\n \nNotice to staffing firms\n \nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.\n","additional":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
\n
\nWho we are
\n
\nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\nNotice to staffing firms
\n
\nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
","categories":{"commitment":"Regular, Full-Time Employee","department":"Commercial","location":"Remote","team":"Sales","allLocations":["Remote"]},"createdAt":1780012408448,"descriptionPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n\n\nPosition Summary: We are seeking qualified, highly motivated, individuals with relevant experience for the position of Regional Account Director on our National Account Management Team. This individual will report directly into the VP of Account Management and Site Enablement, and will be responsible for leading a small team of Orca-T Account Managers (OTAMs) in the United States.\n \nTravel/Location: Recruiting nationally for our first regional leadership position. Willingness to travel up to 50%, based on business needs. \n \n","description":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
Position Summary: We are seeking qualified, highly motivated, individuals with relevant experience for the position of Regional Account Director on our National Account Management Team. This individual will report directly into the VP of Account Management and Site Enablement, and will be responsible for leading a small team of Orca-T Account Managers (OTAMs) in the United States.
\n
\nTravel/Location: Recruiting nationally for our first regional leadership position. Willingness to travel up to 50%, based on business needs.\n
\n
","id":"8c5744f6-0836-47b3-8049-ae57236f0ad7","lists":[{"text":"Key Responsibilities","content":"• Successfully execute the commercial strategy for ORCA T®
• Work collaboratively with cross-functional field-based partners to ensure efficient customer engagement
• Identify, evaluate and assist in authorizing potential ORCA T® treatment sites
• Collaborate with cross-functional internal commercial partners such as marketing, sales training and sales operations to improve efficiency, effectiveness, and maximize teamwork
• Develop, implement and monitor strategy in conjunction with VP of Account Management, Brand Team, Sales Training and Sales Operations to meet and exceed goals
• Develop mechanisms and processes to regularly monitor account activity against goals and provide on-going feedback within organization
• Motivate, train and coach on complex clinical and operational acumen (cell therapy/transplant/oncology/process)
• Performance management; leading/managing individual contributors
• Cascade and compliantly train to brand plan and organizational goals
• Retain top talent and develop individualized career development plans for team
• Work regularly with Orca Therapeutic Account Managers (OTAMs) in the field to provide support and active coaching that deliver on Orca Bio forecast and objectives
• Lead all facets of US Account Management Team in a compliant manner to ensure optimal results
"},{"text":"Qualifications","content":"Required:
\n• 10+ years of experience in healthcare, biotech, or pharmaceutical environment, preferably in cell therapy 4+years of people management experience
• Exemplary leadership skills as demonstrated by cross functional programs & initiatives
• Exceptional oncology clinical and operational acumen
• Extensive Academic experience in oncology
• Academic and large account management experience in oncology
• Exceptional performance management skills
• Experience in building positive team culture grounded in organizational values
• Strong analytical skills
• Proven track record of achieving goals/objectives
• Track record of retaining top talent and career development of high potential team members
• Expertise level/knowledge of compliance and good business conduct principles.
• Strong knowledge of applicable regulatory requirements
• Ability to manage extensive travel
\n
\nPreferred:
\n• MBA
• Demonstrated record of successful oncology account management within an academic setting
• Appropriately access and handle business information in compliance with all applicable laws, regulations and / or Orca Bio policies
• Deep clinical expertise in hematology/oncology disease and understanding of treatment/transplant landscape (5+ years of experience)
• Demonstrated record of successful account management in large accounts (direct or indirect line leadership experience)
• Strong clinical understanding of BMT/Cell therapy and ability to manage complex treatment logistics
• Direct line leadership experience
\n
\nCommunication and Interpersonal Skills:
• Exceptional interpersonal and influencing skills
• Strong written and verbal communication skills
• Ability to build consensus across multiple cross-functional teams
• Proven ability to successfully communicate and execute organizational goals and brand strategies
• Develop significant relationships with Thought Leaders (TLs), senior account level leadership including the C-Suite, as well as other decision makers and influencers
"}],"text":"Regional Account Director, National Account Management Team","country":"US","workplaceType":"remote","opening":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.Position Summary: We are seeking qualified, highly motivated, individuals with relevant experience for the position of Regional Account Director on our National Account Management Team. This individual will report directly into the VP of Account Management and Site Enablement, and will be responsible for leading a small team of Orca-T Account Managers (OTAMs) in the United States.
\n
\nTravel/Location: Recruiting nationally for our first regional leadership position. Willingness to travel up to 50%, based on business needs.\n
\n
","descriptionBodyPlain":"Position Summary: We are seeking qualified, highly motivated, individuals with relevant experience for the position of Regional Account Director on our National Account Management Team. This individual will report directly into the VP of Account Management and Site Enablement, and will be responsible for leading a small team of Orca-T Account Managers (OTAMs) in the United States.\n \nTravel/Location: Recruiting nationally for our first regional leadership position. Willingness to travel up to 50%, based on business needs. \n \n","hostedUrl":"https://jobs.lever.co/orcabiosystems/8c5744f6-0836-47b3-8049-ae57236f0ad7","applyUrl":"https://jobs.lever.co/orcabiosystems/8c5744f6-0836-47b3-8049-ae57236f0ad7/apply"},{"additionalPlain":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. \n \nWho we are\n \nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.\n \nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.\n \nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.\n \nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.\n \nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.\n \nNotice to staffing firms\n \nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.\n","additional":"\n
The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits.
\n
\n
Who we are
\n
\n
We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\n
We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\n
We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\n
We maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\n
We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\n
Notice to staffing firms
\n
\n
Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
\n
\n
More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\n
\n
We are establishing manufacturing operations on the East Coast to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
\n
\n
The Scientist, Quality Control conducts routine and non-routine analysis, including but not limited to biochemical and chemical analysis of processes leading up to drug product according to established operating procedures. The incumbent compiles data for documentation of test procedures, calibrates and maintains lab and analytical equipment; and participates in the preparation of investigations, summaries and reports. The Scientist reviews data obtained for compliance with specifications and reports abnormalities; revises and updates standard operating procedures as needed. May perform special projects.
\n
\n\n
Production Associate Roles: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.\nMost roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.\n\n"}],"salaryRange":{"currency":"USD","interval":"per-year-salary","min":70000,"max":90000},"text":"Scientist, Quality Control","country":"US","workplaceType":"onsite","opening":"","openingPlain":"","descriptionBody":"\n
More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\n
\n
We are establishing manufacturing operations on the East Coast to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
\n
\n
The Scientist, Quality Control conducts routine and non-routine analysis, including but not limited to biochemical and chemical analysis of processes leading up to drug product according to established operating procedures. The incumbent compiles data for documentation of test procedures, calibrates and maintains lab and analytical equipment; and participates in the preparation of investigations, summaries and reports. The Scientist reviews data obtained for compliance with specifications and reports abnormalities; revises and updates standard operating procedures as needed. May perform special projects.
\n
The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
\n
\nWho we are
\n
\nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\nNotice to staffing firms
\n
\nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
","categories":{"commitment":"Regular, Full-Time Employee","department":"General & Administrative","location":"Menlo Park, CA","team":"Accounting","allLocations":["Menlo Park, CA"]},"createdAt":1767054613877,"descriptionPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n\n\nThe Senior Manager / Associate Director, Cost Accounting will lead cost accounting activities for manufacturing and operational functions within a biotechnology or pharmaceutical organization. This role is responsible for overseeing product costing, inventory valuation, COGS reporting, and cost-related controls, while supporting business scaling from clinical-stage through commercialization. The position requires strong leadership, cross-functional partnership, and deep expertise in manufacturing cost structures.\n","description":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
The Senior Manager / Associate Director, Cost Accounting will lead cost accounting activities for manufacturing and operational functions within a biotechnology or pharmaceutical organization. This role is responsible for overseeing product costing, inventory valuation, COGS reporting, and cost-related controls, while supporting business scaling from clinical-stage through commercialization. The position requires strong leadership, cross-functional partnership, and deep expertise in manufacturing cost structures.
","id":"f441dd4e-16a2-4982-aba9-9fb58221181d","lists":[{"text":"Essential Duties & Key Responsibilities","content":"\nCost Accounting & Analysis\nDevelop, own and oversee standard costing, variance analysis, and cost allocations across manufacturing operations\nEstablish and maintain cost accounting policies, procedures, and internal controls\nLead and review monthly close activities related to inventory, COGS, and manufacturing variances\nSupport cost-of-goods-sold (COGS) analysis for clinical and commercial products\n\n
\n\nInventory & Manufacturing Accounting\nMaintain accurate inventory valuation for raw materials, WIP, and finished goods\nAccount for complex manufacturing processes, including batch-based and patient-specific production, where applicable\nPartner with Manufacturing, Supply Chain, and R&D to understand cost drivers and improve cost accuracy\nLead physical inventory counts and cycle count programs\nEnsure proper capitalization and expensing of manufacturing-related costs\n\n
\n\nFinancial Reporting & Compliance\nSupport monthly close activities related to inventory, COGS, and manufacturing variances\nEnsure compliance with GAAP, SOX (if applicable), and internal controls\nAssist with audit requests related to inventory, cost accounting, and manufacturing transactions\nSupport implementation and maintenance of ERP and cost accounting systems\nServe as a primary point of contact for auditors on cost accounting and inventory-related matters\n\n
\n\nBudgeting & Forecasting\nAssist in manufacturing cost forecasts and annual budgets\nMonitor actual costs versus budget and provide variance analysis\nSupport long-range planning related to scale-up, tech transfer, and commercialization\n"},{"text":"Minimum Experience, Education, Certifications, Licenses","content":"\nBachelor’s degree in accounting, Finance, or related field\n5+ years of progressive cost accounting experience in a manufacturing, biotech, or pharmaceutical environment\nStrong understanding of standard costing, inventory accounting, and variance analysis\nExperience working with ERP systems – NetSuite is highly desirable\nStrong Excel skills and data analysis capabilities\nStrong analytical and problem-solving skills\nAbility to work cross-functionally with manufacturing and operations teams\nHigh attention to detail and accuracy\nAbility to manage multiple priorities in a fast-paced environment\n"},{"text":"Preferred Qualifications ","content":"\nExperience in cell therapy, gene therapy, or biologics manufacturing\nKnowledge of GMP manufacturing environments\nCPA preferred but not required\nExperience supporting clinical stage to commercial transition\n"}],"salaryRange":{"min":155000,"max":200000,"currency":"USD","interval":"per-year-salary"},"text":"Senior Manager / Associate Director, Cost Accounting","country":"US","workplaceType":"onsite","opening":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.The Senior Manager / Associate Director, Cost Accounting will lead cost accounting activities for manufacturing and operational functions within a biotechnology or pharmaceutical organization. This role is responsible for overseeing product costing, inventory valuation, COGS reporting, and cost-related controls, while supporting business scaling from clinical-stage through commercialization. The position requires strong leadership, cross-functional partnership, and deep expertise in manufacturing cost structures.
","descriptionBodyPlain":"The Senior Manager / Associate Director, Cost Accounting will lead cost accounting activities for manufacturing and operational functions within a biotechnology or pharmaceutical organization. This role is responsible for overseeing product costing, inventory valuation, COGS reporting, and cost-related controls, while supporting business scaling from clinical-stage through commercialization. The position requires strong leadership, cross-functional partnership, and deep expertise in manufacturing cost structures.\n","hostedUrl":"https://jobs.lever.co/orcabiosystems/f441dd4e-16a2-4982-aba9-9fb58221181d","applyUrl":"https://jobs.lever.co/orcabiosystems/f441dd4e-16a2-4982-aba9-9fb58221181d/apply"},{"additionalPlain":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.\n \nWho we are\n \nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.\n \nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.\n \nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.\n \nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.\n \nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.\n \nNotice to staffing firms\n \nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.\n","additional":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
\n
\nWho we are
\n
\nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\nNotice to staffing firms
\n
\nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
","categories":{"commitment":"Regular, Full-Time Employee","department":"General & Administrative","location":"Menlo Park, CA","team":"Legal","allLocations":["Menlo Park, CA","Remote"]},"createdAt":1770228254855,"descriptionPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n\n\nPosition Summary: Orca Bio is building its first in-house healthcare compliance function and is seeking a motivated and adaptable compliance professional to support the development and execution of that program. Reporting to the SVP/Head of Legal, the Senior Manager or Associate Director, Healthcare Compliance will work cross-functionally to lead key elements of a pre-commercial compliance program—including policy and SOP development, transparency and aggregate spend reporting, training, and commercial and promotional compliance review. The role will also support future field engagements following potential product approval.\n \nTravel: ~25%. Remote applicants accepted, with preference for those near Orca Bio HQ.\n","description":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
Position Summary: Orca Bio is building its first in-house healthcare compliance function and is seeking a motivated and adaptable compliance professional to support the development and execution of that program. Reporting to the SVP/Head of Legal, the Senior Manager or Associate Director, Healthcare Compliance will work cross-functionally to lead key elements of a pre-commercial compliance program—including policy and SOP development, transparency and aggregate spend reporting, training, and commercial and promotional compliance review. The role will also support future field engagements following potential product approval.
\n
\nTravel: ~25%. Remote applicants accepted, with preference for those near Orca Bio HQ.
","id":"e7380c5e-5979-4725-b777-723736fef150","lists":[{"text":"Key Responsibilities","content":"\nAssist in the ongoing development, implementation, and maintenance of the Company’s compliance program that aligns with industry standards and regulatory requirements, including federal, state, and international regulations, as appropriate.\nDevelop policies and procedures that provide appropriate guidance and instruction to Company employees.\nLead the development and delivery of compliance training programs for employees at all levels.\nConduct regular compliance audits, monitoring and risk assessments to identify potential areas of compliance vulnerability and risk.\nAssist in the completion of activities related to federal and relevant state transparency-driven compliance requirements. \nManage the Company’s whistleblower hotline.\nCollaborate with legal, regulatory, and operational teams to provide compliance guidance and support for new initiatives and projects.\nInvestigate compliance-related issues and coordinate with relevant stakeholders to ensure appropriate corrective actions are taken.\nStay current with industry trends, regulatory changes, and best practices in compliance.\nEngage in such other activities as directed by the Senior Vice President, Legal. \n"},{"text":"Required Experience:","content":"\nBachelor’s degree in life sciences, law, business, or a related field; advanced degree (e.g., JD, MBA) preferred.\nMinimum of 6 years of experience in compliance, regulatory affairs, or a related field within the pharmaceutical or biotech industry.\nStrong knowledge of FDA regulations, GxP standards, and other relevant compliance frameworks.\nProven ability to interpret and apply complex regulations and guidelines to business practices.\nExcellent analytical, problem-solving skills.\nWell-rounded, experienced compliance expert who has played a key role on matters relating to the marketing and promotion of pharmaceutical products and possesses excellent business judgment concerning overall healthcare compliance and risk management.\nAbility to work effectively in cross-functional teams with a collaborative and hands-on approach.\nAbility to manage multiple tasks independently and simultaneously.\n"}],"salaryRange":{"min":160000,"max":200000,"currency":"USD","interval":"per-year-salary"},"text":"Senior Manager / Associate Director, Healthcare Compliance","country":"US","workplaceType":"remote","opening":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.Position Summary: Orca Bio is building its first in-house healthcare compliance function and is seeking a motivated and adaptable compliance professional to support the development and execution of that program. Reporting to the SVP/Head of Legal, the Senior Manager or Associate Director, Healthcare Compliance will work cross-functionally to lead key elements of a pre-commercial compliance program—including policy and SOP development, transparency and aggregate spend reporting, training, and commercial and promotional compliance review. The role will also support future field engagements following potential product approval.
\n
\nTravel: ~25%. Remote applicants accepted, with preference for those near Orca Bio HQ.
","descriptionBodyPlain":"Position Summary: Orca Bio is building its first in-house healthcare compliance function and is seeking a motivated and adaptable compliance professional to support the development and execution of that program. Reporting to the SVP/Head of Legal, the Senior Manager or Associate Director, Healthcare Compliance will work cross-functionally to lead key elements of a pre-commercial compliance program—including policy and SOP development, transparency and aggregate spend reporting, training, and commercial and promotional compliance review. The role will also support future field engagements following potential product approval.\n \nTravel: ~25%. Remote applicants accepted, with preference for those near Orca Bio HQ.\n","hostedUrl":"https://jobs.lever.co/orcabiosystems/e7380c5e-5979-4725-b777-723736fef150","applyUrl":"https://jobs.lever.co/orcabiosystems/e7380c5e-5979-4725-b777-723736fef150/apply"},{"additionalPlain":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.\n \nWho we are\n \nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.\n \nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.\n \nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.\n \nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.\n \nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.\n \nNotice to staffing firms\n \nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.\n","additional":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
\n
\nWho we are
\n
\nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\nNotice to staffing firms
\n
\nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
","categories":{"commitment":"Regular, Full-Time Employee","department":"Operations","location":"Sacramento, CA","team":"Facilities","allLocations":["Sacramento, CA"]},"createdAt":1780512371923,"descriptionPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n \nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.\n\n\nThe Senior Manager, Facilities is responsible for overseeing and maintaining the physical tenant infrastructure, operating and maintaining all utility systems, managing service providers, maintaining GMP and safety compliance, and serving as the liaison with the building landlord. They will work closely with other departments to support the overall goals of the organization.\n","description":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
The Senior Manager, Facilities is responsible for overseeing and maintaining the physical tenant infrastructure, operating and maintaining all utility systems, managing service providers, maintaining GMP and safety compliance, and serving as the liaison with the building landlord. They will work closely with other departments to support the overall goals of the organization.
","id":"284e7069-0465-4f79-ae13-7708b21cebab","lists":[{"text":"Facility Operations & Maintenance:","content":"\n\nOversee the day-to-day operations and maintenance of the facility, ensuring all systems are functioning properly (HVAC, chilled water, heating hot water, clean dry air, electrical distribution, emergency generator, uninterruptible power, RODI water, domestic water systems, etc)
\n\n\nManage service provider relationships (cleaning, pest control, security, maintenance and technical support services, etc.), ensuring delivery of quality services and compliance with service agreements.
\n\n\nDevelop, implement and manage preventive maintenance and calibration programs to ensure the facility is GMP compliant.
\n\n\nCollaborate with Facilities and Production Planning to schedule and coordinate repairs and maintenance activities for building systems and equipment.
\n\n\nEnsure accurate record-keeping for facility operations, and equipment maintenance, including Computerize Maintenance Management System (CMMS) and logbooks.
\n\n\nAnalyze, troubleshoot, and resolve system/equipment performance, malfunctions, or failures
\n\n\nTrack and report on system/equipment downtime, failure trends and develop corrective actions to prevent recurrence
\n\n\nCoordination and execution of onsite and preventative and corrective maintenance, calibration and certification activities completed by service providers
\n\n\nReview and approval of service provider documentation, and completion and closeout of tasks in the CMMS
\n\n"},{"text":"Health, Safety & Compliance:","content":"\n\n
\nEnsure the facility complies with all relevant safety, environmental, and regulatory requirements (e.g., OSHA, GMP, FDA, local building codes).
\n\n
\nParticipate in regular inspections to identify and mitigate risks related to safety, health, and environmental impacts.
\n\n\n
\n\n\n
Support development and management of the facility’s operational and maintenance budget, controlling costs related to maintenance, repairs and outside services.\n\n"},{"text":"Project Management:","content":"\n\n
\nPlan and coordinate facility-related projects such as improvements or expansions.
\n\n
\nManage projects related to the installation of new equipment.
\n\n
\nWork with other departments and external contractors and vendors to ensure successful project execution.
\n\n\n
\n\n
Bachelor’s degree in Facility Management, Engineering, or related field preferred, or equivalent job experience. \n\n"},{"text":"Experience Requirement: ","content":"\n\n
7-10 years of experience in facility operations and management in a GMP environment, preferably in the cell therapy, biotechnology or pharmaceutical industry.\n\n"},{"text":"Skill Requirement:","content":"\n\n
\nStrong knowledge of building systems operations (HVAC, RODI, compressed air, domestic water, electrical), maintenance and calibration programs, GMP regulatory standards, and safety requirements in the biopharmaceutical/cell therapy industry.
\n\n
\nExcellent leadership, communication, and interpersonal skills.
\n\n
\nExperience/proficiency with maintenance management software and systems.
\n\n
\nExcellent project and time management skills with the ability to oversee multiple tasks at once.
\n\n
\nBudgeting experience.
\n\n
\nProblem-solving and troubleshooting, and ability to make sound decisions.
\n\n\n
\n\n
The position requires on-site presence and regular work hours but may require on-call availability and after-hours presence for planned or unplanned work, or emergency response. \n\n"}],"salaryRange":{"min":125000,"max":165000,"currency":"USD","interval":"per-year-salary"},"text":"Senior Manager, Facilities","country":"US","workplaceType":"onsite","opening":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
","openingPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n \nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.\n","descriptionBody":"The Senior Manager, Facilities is responsible for overseeing and maintaining the physical tenant infrastructure, operating and maintaining all utility systems, managing service providers, maintaining GMP and safety compliance, and serving as the liaison with the building landlord. They will work closely with other departments to support the overall goals of the organization.
","descriptionBodyPlain":"The Senior Manager, Facilities is responsible for overseeing and maintaining the physical tenant infrastructure, operating and maintaining all utility systems, managing service providers, maintaining GMP and safety compliance, and serving as the liaison with the building landlord. They will work closely with other departments to support the overall goals of the organization.\n","hostedUrl":"https://jobs.lever.co/orcabiosystems/284e7069-0465-4f79-ae13-7708b21cebab","applyUrl":"https://jobs.lever.co/orcabiosystems/284e7069-0465-4f79-ae13-7708b21cebab/apply"},{"additionalPlain":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.\n \nWho we are\n \nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.\n \nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.\n \nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.\n \nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.\n \nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.\n \nNotice to staffing firms\n \nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.\n","additional":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
\n
\nWho we are
\n
\nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\nNotice to staffing firms
\n
\nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
","categories":{"commitment":"Regular, Full-Time Employee","department":"Operations","location":"Sacramento, CA","team":"Logistics & Product Supply","allLocations":["Sacramento, CA"]},"createdAt":1759945685969,"descriptionPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n \nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.\n\n\nThe Specialist, Logistics ensures the secure and timely transport of donor cells and drug products between Orca Bio’s manufacturing sites and transplant centers. This role is responsible for scheduling couriers, coordinating logistics with internal stakeholders and external donor and recipient organizations, and maintaining compliance with regulatory requirements. The ideal candidate is proactive, solutions-oriented, and able to work independently in a fast-paced environment, with strong attention to detail, a sense of urgency, and the ability to troubleshoot issues in real time.\n","description":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
The Specialist, Logistics ensures the secure and timely transport of donor cells and drug products between Orca Bio’s manufacturing sites and transplant centers. This role is responsible for scheduling couriers, coordinating logistics with internal stakeholders and external donor and recipient organizations, and maintaining compliance with regulatory requirements. The ideal candidate is proactive, solutions-oriented, and able to work independently in a fast-paced environment, with strong attention to detail, a sense of urgency, and the ability to troubleshoot issues in real time.
","id":"cdd86b7a-5a75-4ed5-bafd-f0912b0b2478","lists":[{"text":"Physical Demands","content":"\nProduction Associate Roles: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.\nMost roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.\n"},{"text":"Work Conditions","content":"\nMany roles must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video-based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs.\n"},{"text":"Key Responsibilities","content":"\nSchedule couriers to facilitate donor cell pickups and deliveries to Orca Bio manufacturing sites in Sacramento.\nCoordinate outbound shipments of patient drug products to recipient sites.\nManage flight and travel logistics for couriers, liaising with airlines and travel providers.\nActively monitor shipments and proactively resolve any delays or issues in real time.\nCommunicate changes urgently and professionally with all impacted stakeholders.\nPartner with clinical schedulers and commercial case managers to troubleshoot and triage non-routine issues during transports.\nEnsure all documentation and compliance requirements for pickups and deliveries are met.\nSupport communication flow between internal teams, couriers, and external partners to ensure secure and timely deliveries.\nLiaise with third-party couriers and troubleshoot transportation issues as they arise.\nReview and approve courier invoices; assist in performance tracking and optimization.\nContribute to training materials and ensure the courier team remains compliant and current.\nContinuously evaluate and improve logistics workflows to support operational scalability.\nParticipate in on-call coverage during active courier transports to handle non-routine issues.\nAssist with additional logistics and operations-related projects as needed.\n"},{"text":"Education & Experience","content":"\nBachelors degree and 2–3 years of relevant logistics experience required. B.S. in biology, life sciences, or logistics preferred.\nProven success in logistics coordination, preferably in a regulated environment.\nFamiliarity with handling biological materials and associated transportation regulations is a plus.\nProficiency in logistics tracking systems or software required.\n"},{"text":"Preferred Experience","content":"\nLogistics or courier coordination in fast-paced, time-sensitive industries (e.g., healthcare, biotech, or medical transport).\nWorking with regulated materials, such as biological specimens or pharmaceuticals, with knowledge of chain-of-custody, IATA, or DOT compliance.\nReal-time problem-solving and communication during transport disruptions or delays.\nManaging relationships with vendors, third-party couriers, airlines, and internal stakeholders simultaneously.\nExposure to continuous improvement efforts, workflow scaling, or SOP development.\nFamiliarity with logistics tools and platforms such as shipment tracking systems, Google Workspace, Smartsheet, or equivalent.\n"},{"text":"Personal Qualities","content":"\nHighly detail-oriented, with an unwavering commitment to quality, safety, and compliance.\nTakes ownership and drives forward without waiting for instruction.\nIs naturally curious, eager to learn, and energized by solving problems.\nBrings creative solutions to unexpected challenges.\nIs comfortable juggling multiple priorities in a fast-paced, startup environment.\nCommunicates clearly and professionally with internal and external stakeholders.\nWorks both independently and collaboratively with a team-first mindset.\nStays calm under pressure and adapts quickly to change.\nEmbraces a positive attitude, a collaborative spirit, and a good sense of humor.\nCan work flexible or off-shift hours to support urgent logistics needs.\n"}],"salaryRange":{"min":60000,"max":90000,"currency":"USD","interval":"per-year-salary"},"text":"Specialist, Logistics Program","country":"US","workplaceType":"onsite","opening":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
","openingPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n \nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.\n","descriptionBody":"The Specialist, Logistics ensures the secure and timely transport of donor cells and drug products between Orca Bio’s manufacturing sites and transplant centers. This role is responsible for scheduling couriers, coordinating logistics with internal stakeholders and external donor and recipient organizations, and maintaining compliance with regulatory requirements. The ideal candidate is proactive, solutions-oriented, and able to work independently in a fast-paced environment, with strong attention to detail, a sense of urgency, and the ability to troubleshoot issues in real time.
","descriptionBodyPlain":"The Specialist, Logistics ensures the secure and timely transport of donor cells and drug products between Orca Bio’s manufacturing sites and transplant centers. This role is responsible for scheduling couriers, coordinating logistics with internal stakeholders and external donor and recipient organizations, and maintaining compliance with regulatory requirements. The ideal candidate is proactive, solutions-oriented, and able to work independently in a fast-paced environment, with strong attention to detail, a sense of urgency, and the ability to troubleshoot issues in real time.\n","hostedUrl":"https://jobs.lever.co/orcabiosystems/cdd86b7a-5a75-4ed5-bafd-f0912b0b2478","applyUrl":"https://jobs.lever.co/orcabiosystems/cdd86b7a-5a75-4ed5-bafd-f0912b0b2478/apply"},{"additionalPlain":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.\n \nWho we are\n \nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.\n \nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.\n \nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.\n \nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.\n \nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.\n \nNotice to staffing firms\n \nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.\n","additional":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
\n
\nWho we are
\n
\nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\nNotice to staffing firms
\n
\nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
","categories":{"commitment":"Regular, Full-Time Employee","department":"Quality","location":"Sacramento, CA","team":"Quality Assurance","allLocations":["Sacramento, CA"]},"createdAt":1776878394276,"descriptionPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n \nWe operate a dedicated clinical manufacturing facility in Sacramento, CA (3400 Business Drive), which has historically served as the foundation for producing our high-precision cell therapy products. This site plays a critical role in advancing our clinical pipeline and ensuring the consistent, reliable supply of therapies for patients participating in our trials.\n\n\nThe Specialist, Quality Assurance position is a key role in meeting the quality policy through their management of the different quality systems, including production records and deviation system management. The ideal candidate will be responsible for managing the quality systems, including deviations, change control, corrective and preventive actions (CAPA), and document management. Additionally, this role involves making timely batch disposition decisions to ensure quality standards are met before product release, supporting the rapid processing times required by our product. You will have the unique opportunity to make a difference in the lives of many patients as Orca Bio develops next-generation cell therapies.\n","description":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\nWe operate a dedicated clinical manufacturing facility in Sacramento, CA (3400 Business Drive), which has historically served as the foundation for producing our high-precision cell therapy products. This site plays a critical role in advancing our clinical pipeline and ensuring the consistent, reliable supply of therapies for patients participating in our trials.
The Specialist, Quality Assurance position is a key role in meeting the quality policy through their management of the different quality systems, including production records and deviation system management. The ideal candidate will be responsible for managing the quality systems, including deviations, change control, corrective and preventive actions (CAPA), and document management. Additionally, this role involves making timely batch disposition decisions to ensure quality standards are met before product release, supporting the rapid processing times required by our product. You will have the unique opportunity to make a difference in the lives of many patients as Orca Bio develops next-generation cell therapies.
","id":"7e9f53d8-2b1a-4c56-ba3a-926cd74a66d7","lists":[{"text":"Physical Demands","content":"\nProduction Associates: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.\nMust be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.\n"},{"text":"Work Conditions","content":"\nMust be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.\nMust be comfortable regularly participating in video-based meetings.\nMay be required to work scheduled overtime, weekends, or holidays based on business needs.\n"},{"text":"Responsibilities","content":"Quality System Management:
\n\nOversee the management of quality systems including deviations, change controls, CAPAs, and document control.\nEnsure that all deviations are investigated thoroughly and timely, identifying root causes and implementing effective corrective actions.\nReview and approve change controls to ensure compliance with regulatory requirements and internal procedures.\nMaintain and improve CAPA processes to ensure effective resolution of quality issues.\n\nBatch Disposition:
\n\nEvaluate batch records and associated documentation to make informed batch release decisions.\nCollaborate with manufacturing and quality control teams to ensure all products meet regulatory and quality standards before release.\nMonitor and document any quality issues related to batch production and implement corrective measures as necessary.\n\nDocument Management:
\n\nMaintain the document management system to ensure all quality-related documents are accurate, current, and compliant with regulatory standards.\nConduct regular reviews of quality documentation to ensure adherence to established protocols and procedures.\n\nRegulatory Compliance:
\n\nStay informed of current regulations, industry trends, and best practices in pharmaceutical quality assurance.\nAssist in preparing for internal and external audits, ensuring that all quality systems and documentation are audit-ready.\n\nTraining and Support:
\n\nProvide training and guidance to staff on quality systems, processes, and compliance requirements.\nServe as a point of contact for quality-related inquiries and issues, fostering a culture of quality within the organization.\n\nContinuous Improvement:
\n\nParticipate in continuous improvement initiatives to enhance the effectiveness and efficiency of quality systems and processes.\nIdentify areas for improvement within quality operations and suggest appropriate solutions.\nTrack completion of quality records and maintain metrics.\nPerform other duties as requested by supervisor/manager to support Quality\nWork collaboratively with cross-functional teams, including manufacturing, research and development, and quality assurance, to support the overall quality of cell therapy products.\n"},{"text":"General Requirements","content":"\nCommunicate effectively with team members and contribute to a positive and collaborative work environment\nActively participate in group and project teamwork; project and process improvements\nStrong organizational skills and the ability to manage multiple tasks concurrently\nWillingness to learn and adapt in a fast-paced, dynamic environment\nAdhere to cGMP policies and procedures, including documentation activities\nAble to wear appropriate personal protective equipment\nWillingness to work overtime as required\nBe available to provide on-call support outside regular business hours as needed \n"},{"text":"Experienced Required","content":"\nBachelor’s degree in a relevant scientific discipline (biology, biochemistry, immunology, etc.) with 3+ years of experience in quality control testing, analytical development, or GMP; OR a Master’s degree in relevant scientific disciplines with 1+ years of experience\nUnderstanding of FDA regulations, GMP compliance, and quality system processes\nExperience in quality control or GMP within a cell therapy or biopharmaceutical manufacturing environment is preferred\nAble to meet project and testing timelines\nDetail-oriented with a commitment to data integrity and accuracy, and an ability to identify problems with data management\nAble to work collaboratively to respond to changing priorities and challenges\nAbility to work both independently and collaboratively with a multi-disciplinary team in a fast-paced and regulated environment\nPrior experience doing internal audits and document control management\n"}],"salaryRange":{"min":75000,"max":90000,"currency":"USD","interval":"per-year-salary"},"text":"Specialist, Quality Assurance - Day Shift","country":"US","workplaceType":"onsite","opening":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\nWe operate a dedicated clinical manufacturing facility in Sacramento, CA (3400 Business Drive), which has historically served as the foundation for producing our high-precision cell therapy products. This site plays a critical role in advancing our clinical pipeline and ensuring the consistent, reliable supply of therapies for patients participating in our trials.
","openingPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n \nWe operate a dedicated clinical manufacturing facility in Sacramento, CA (3400 Business Drive), which has historically served as the foundation for producing our high-precision cell therapy products. This site plays a critical role in advancing our clinical pipeline and ensuring the consistent, reliable supply of therapies for patients participating in our trials.\n","descriptionBody":"The Specialist, Quality Assurance position is a key role in meeting the quality policy through their management of the different quality systems, including production records and deviation system management. The ideal candidate will be responsible for managing the quality systems, including deviations, change control, corrective and preventive actions (CAPA), and document management. Additionally, this role involves making timely batch disposition decisions to ensure quality standards are met before product release, supporting the rapid processing times required by our product. You will have the unique opportunity to make a difference in the lives of many patients as Orca Bio develops next-generation cell therapies.
","descriptionBodyPlain":"The Specialist, Quality Assurance position is a key role in meeting the quality policy through their management of the different quality systems, including production records and deviation system management. The ideal candidate will be responsible for managing the quality systems, including deviations, change control, corrective and preventive actions (CAPA), and document management. Additionally, this role involves making timely batch disposition decisions to ensure quality standards are met before product release, supporting the rapid processing times required by our product. You will have the unique opportunity to make a difference in the lives of many patients as Orca Bio develops next-generation cell therapies.\n","hostedUrl":"https://jobs.lever.co/orcabiosystems/7e9f53d8-2b1a-4c56-ba3a-926cd74a66d7","applyUrl":"https://jobs.lever.co/orcabiosystems/7e9f53d8-2b1a-4c56-ba3a-926cd74a66d7/apply"},{"additionalPlain":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.\n \nWho we are\n \nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.\n \nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.\n \nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.\n \nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.\n \nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.\n \nNotice to staffing firms\n \nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.\n","additional":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
\n
\nWho we are
\n
\nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\nNotice to staffing firms
\n
\nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
","categories":{"commitment":"Regular, Full-Time Employee","department":"Quality","location":"Sacramento, CA","team":"Quality Assurance","allLocations":["Sacramento, CA"]},"createdAt":1776441994454,"descriptionPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n \nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.\n\n\nThe Specialist, Quality Assurance position is a key role in meeting the quality policy through their management of the different quality systems, including production records and deviation system management. The ideal candidate will be responsible for managing the quality systems, including deviations, change control, corrective and preventive actions (CAPA), and document management. Additionally, this role involves making timely batch disposition decisions to ensure quality standards are met before product release, supporting the rapid processing times required by our product. You will have the unique opportunity to make a difference in the lives of many patients as Orca Bio develops next-generation cell therapies.\n","description":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
The Specialist, Quality Assurance position is a key role in meeting the quality policy through their management of the different quality systems, including production records and deviation system management. The ideal candidate will be responsible for managing the quality systems, including deviations, change control, corrective and preventive actions (CAPA), and document management. Additionally, this role involves making timely batch disposition decisions to ensure quality standards are met before product release, supporting the rapid processing times required by our product. You will have the unique opportunity to make a difference in the lives of many patients as Orca Bio develops next-generation cell therapies.
","id":"1406db26-b94b-44a1-ae39-75516412ec00","lists":[{"text":"Physical Demands","content":"\nProduction Associate Roles: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.\nMost roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.\n"},{"text":"Work Conditions","content":"\nMany roles must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video-based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs.\n"},{"text":"Responsibilities","content":"Quality System Management:
\n\nOversee the management of quality systems including deviations, change controls, CAPAs, and document control.\nEnsure that all deviations are investigated thoroughly and timely, identifying root causes and implementing effective corrective actions.\nReview and approve change controls to ensure compliance with regulatory requirements and internal procedures.\nMaintain and improve CAPA processes to ensure effective resolution of quality issues.\n\nBatch Disposition:
\n\nEvaluate batch records and associated documentation to make informed batch release decisions.\nCollaborate with manufacturing and quality control teams to ensure all products meet regulatory and quality standards before release.\nMonitor and document any quality issues related to batch production and implement corrective measures as necessary.\n\nDocument Management:
\n\nMaintain the document management system to ensure all quality-related documents are accurate, current, and compliant with regulatory standards.\nConduct regular reviews of quality documentation to ensure adherence to established protocols and procedures.\n\nRegulatory Compliance:
\n\nStay informed of current regulations, industry trends, and best practices in pharmaceutical quality assurance.\nAssist in preparing for internal and external audits, ensuring that all quality systems and documentation are audit-ready.\n\nTraining and Support:
\n\nProvide training and guidance to staff on quality systems, processes, and compliance requirements.\nServe as a point of contact for quality-related inquiries and issues, fostering a culture of quality within the organization.\n\nContinuous Improvement:
\n\nParticipate in continuous improvement initiatives to enhance the effectiveness and efficiency of quality systems and processes.\nIdentify areas for improvement within quality operations and suggest appropriate solutions.\nTrack completion of quality records and maintain metrics.\nPerform other duties as requested by supervisor/manager to support Quality\nWork collaboratively with cross-functional teams, including manufacturing, research and development, and quality assurance, to support the overall quality of cell therapy products.\n"},{"text":"General Requirements","content":"\nCommunicate effectively with team members and contribute to a positive and collaborative work environment\nActively participate in group and project teamwork; project and process improvements\nStrong organizational skills and the ability to manage multiple tasks concurrently\nWillingness to learn and adapt in a fast-paced, dynamic environment\nAdhere to cGMP policies and procedures, including documentation activities\nAble to wear appropriate personal protective equipment\nWillingness to work overtime as required\n"},{"text":"Experienced Required","content":"\nBachelor’s degree in a relevant scientific discipline (biology, biochemistry, immunology, etc.) with 3+ years of experience in quality control testing, analytical development, or GMP; OR a Master’s degree in relevant scientific disciplines with 1+ years of experience\nUnderstanding of FDA regulations, GMP compliance, and quality system processes\nExperience in quality control or GMP within a cell therapy or biopharmaceutical manufacturing environment is preferred\nAble to meet project and testing timelines\nDetail-oriented with a commitment to data integrity and accuracy, and an ability to identify problems with data management\nAble to work collaboratively to respond to changing priorities and challenges\nAbility to work both independently and collaboratively with a multi-disciplinary team in a fast-paced and regulated environment\nPrior experience doing internal audits and document control management\n"}],"salaryRange":{"min":75000,"max":90000,"currency":"USD","interval":"per-year-salary"},"text":"Specialist, Quality Assurance - Weekend Shift (Friday-Monday)","country":"US","workplaceType":"onsite","opening":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
","openingPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n \nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.\n","descriptionBody":"The Specialist, Quality Assurance position is a key role in meeting the quality policy through their management of the different quality systems, including production records and deviation system management. The ideal candidate will be responsible for managing the quality systems, including deviations, change control, corrective and preventive actions (CAPA), and document management. Additionally, this role involves making timely batch disposition decisions to ensure quality standards are met before product release, supporting the rapid processing times required by our product. You will have the unique opportunity to make a difference in the lives of many patients as Orca Bio develops next-generation cell therapies.
","descriptionBodyPlain":"The Specialist, Quality Assurance position is a key role in meeting the quality policy through their management of the different quality systems, including production records and deviation system management. The ideal candidate will be responsible for managing the quality systems, including deviations, change control, corrective and preventive actions (CAPA), and document management. Additionally, this role involves making timely batch disposition decisions to ensure quality standards are met before product release, supporting the rapid processing times required by our product. You will have the unique opportunity to make a difference in the lives of many patients as Orca Bio develops next-generation cell therapies.\n","hostedUrl":"https://jobs.lever.co/orcabiosystems/1406db26-b94b-44a1-ae39-75516412ec00","applyUrl":"https://jobs.lever.co/orcabiosystems/1406db26-b94b-44a1-ae39-75516412ec00/apply"},{"additionalPlain":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.\n \nWho we are\n \nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.\n \nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.\n \nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.\n \nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.\n \nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.\n \nNotice to staffing firms\n \nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.\n","additional":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
\n
\nWho we are
\n
\nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\nNotice to staffing firms
\n
\nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
","categories":{"commitment":"Regular, Full-Time Employee","department":"Manufacturing","location":"Sacramento, CA","team":"Training","allLocations":["Sacramento, CA"]},"createdAt":1777071460314,"descriptionPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n \nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.\n\n\nThe Specialist, Training works to develop, deliver and optimize classroom and hands on training programs that support the development and enhancement of skills related to GMP operations in a commercial manufacturing environment. The role ensures that personnel are trained effectively on standard operating procedures (SOPs), equipment use, safety protocols, and regulatory compliance to achieve production goals and maintain quality standards.\nNight Shift Hours Worked:\n• 6:00pm to 6:30am or\n• 6:30pm to 7:00am\n \nWork Week Schedule:\n• Sunday, Monday, Tuesday + every other Wednesday or\n• Thursday, Friday, Saturday + every other Wednesday\n","description":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
The Specialist, Training works to develop, deliver and optimize classroom and hands on training programs that support the development and enhancement of skills related to GMP operations in a commercial manufacturing environment. The role ensures that personnel are trained effectively on standard operating procedures (SOPs), equipment use, safety protocols, and regulatory compliance to achieve production goals and maintain quality standards.
\nNight Shift Hours Worked:
\n• 6:00pm to 6:30am or
\n• 6:30pm to 7:00am
\n
\nWork Week Schedule:
\n• Sunday, Monday, Tuesday + every other Wednesday or
\n• Thursday, Friday, Saturday + every other Wednesday
","id":"a51eec36-3cd7-450c-aa90-25e48c586714","lists":[{"text":"Physical Demands","content":"\nProduction Associate Roles: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.\nMost roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.\n"},{"text":"Work Conditions","content":"\nMany roles must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video-based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs.\n"},{"text":"Key Responsibilities:","content":"\nDevelop comprehensive training programs and materials for roles across the GMP commercial operations of cell therapies including, but not limited to, manufacturing, quality control, and warehousing.\nCreate training modules, presentations, and manuals that align with regulatory requirements, GMP guidelines, and company policies.\nConduct classroom training sessions, workshops, on the job training, and hands-on demonstrations, on a daily basis, to impart technical knowledge and skills to staff.\nAssess trainee competencies and learning outcomes through practical evaluations and knowledge assessments.\nProvide constructive feedback and coaching to trainees to support their skill development and performance improvement.\nMaintain accurate training records and documentation to demonstrate compliance with training requirements.\nOptimizes training programs to support scalability and reduced time to operator proficiency.\nMay require shift, weekend, or holiday coverage to support manufacturing and patient treatment timelines.\nSupports training system compliance and other duties as assigned\n"},{"text":"Minimum Qualifications","content":"\nBachelor's degree in a relevant field such as Biotechnology, Engineering, or Education; advanced degree preferred\nMinimum of 2 years of relevant experience in training and development, preferably in a manufacturing or biotechnology environment\nStrong understanding of cGMP regulations, FDA guidelines, and other relevant quality standards applicable to pharmaceutical or biotech manufacturing\nExcellent communication, presentation, and interpersonal skills, with the ability to engage and motivate diverse audiences\nProven ability to manage multiple projects concurrently, prioritize tasks effectively, and adapt to changing priorities in a fast-paced environment\nProficiency in MS Office applications and learning management systems (LMS) is required\n"},{"text":"Preferred Qualifications","content":"\nExperience in quality control or GMP within a cell therapy or biopharmaceutical manufacturing environment is preferred\n2+ years of experience in quality control testing, analytical development, or GMP quality operations\n"}],"salaryRange":{"min":68000,"max":95000,"currency":"USD","interval":"per-year-salary"},"text":"Specialist, Training - Night Shift","country":"US","workplaceType":"onsite","opening":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
","openingPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n \nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.\n","descriptionBody":"The Specialist, Training works to develop, deliver and optimize classroom and hands on training programs that support the development and enhancement of skills related to GMP operations in a commercial manufacturing environment. The role ensures that personnel are trained effectively on standard operating procedures (SOPs), equipment use, safety protocols, and regulatory compliance to achieve production goals and maintain quality standards.
\nNight Shift Hours Worked:
\n• 6:00pm to 6:30am or
\n• 6:30pm to 7:00am
\n
\nWork Week Schedule:
\n• Sunday, Monday, Tuesday + every other Wednesday or
\n• Thursday, Friday, Saturday + every other Wednesday
","descriptionBodyPlain":"The Specialist, Training works to develop, deliver and optimize classroom and hands on training programs that support the development and enhancement of skills related to GMP operations in a commercial manufacturing environment. The role ensures that personnel are trained effectively on standard operating procedures (SOPs), equipment use, safety protocols, and regulatory compliance to achieve production goals and maintain quality standards.\nNight Shift Hours Worked:\n• 6:00pm to 6:30am or\n• 6:30pm to 7:00am\n \nWork Week Schedule:\n• Sunday, Monday, Tuesday + every other Wednesday or\n• Thursday, Friday, Saturday + every other Wednesday\n","hostedUrl":"https://jobs.lever.co/orcabiosystems/a51eec36-3cd7-450c-aa90-25e48c586714","applyUrl":"https://jobs.lever.co/orcabiosystems/a51eec36-3cd7-450c-aa90-25e48c586714/apply"},{"additionalPlain":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.\n \nWho we are\n \nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.\n \nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.\n \nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.\n \nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.\n \nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.\n \nNotice to staffing firms\n \nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.\n","additional":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
\n
\nWho we are
\n
\nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\nNotice to staffing firms
\n
\nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
","categories":{"commitment":"Regular, Full-Time Employee","department":"Manufacturing","location":"Sacramento, CA","team":"Production","allLocations":["Sacramento, CA"]},"createdAt":1778540395748,"descriptionPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n \nWe operate a dedicated clinical manufacturing facility in Sacramento, CA (3400 Business Drive), which has historically served as the foundation for producing our high-precision cell therapy products. This site plays a critical role in advancing our clinical pipeline and ensuring the consistent, reliable supply of therapies for patients participating in our trials.\n\n\nThis is a 2nd shift-based position, working on-site Monday through Friday, from 3 pm to 11:30 pm. The Supervisor, Clinical Manufacturing plays a critical role overseeing the production of Orca’s cell therapy products, ensuring adherence to strict quality standards, regulatory requirements and aseptic production techniques. This position works on shift to provide supervision and direction to associates, cell therapy production, oncology to ensure timely and compliant manufacturing.\n","description":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\nWe operate a dedicated clinical manufacturing facility in Sacramento, CA (3400 Business Drive), which has historically served as the foundation for producing our high-precision cell therapy products. This site plays a critical role in advancing our clinical pipeline and ensuring the consistent, reliable supply of therapies for patients participating in our trials.
This is a 2nd shift-based position, working on-site Monday through Friday, from 3 pm to 11:30 pm. The Supervisor, Clinical Manufacturing plays a critical role overseeing the production of Orca’s cell therapy products, ensuring adherence to strict quality standards, regulatory requirements and aseptic production techniques. This position works on shift to provide supervision and direction to associates, cell therapy production, oncology to ensure timely and compliant manufacturing.
","id":"7b859745-4187-45d6-84e3-ecb1e3d5780b","lists":[{"text":"Physical Demands","content":"\nProduction Associates: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.\nMust be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.\n"},{"text":"Work Conditions","content":"\nMust be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.\nMust be comfortable regularly participating in video-based meetings.\nMay be required to work scheduled overtime, weekends, or holidays based on business needs.\n"},{"text":"Essential Duties & Key Responsibilities","content":"\nSupervise and lead a team of associates, cell therapy production, oncology during assigned shift operations. \nCoordinate daily manufacturing activities to meet schedule, and quality and compliance goals. \nExecute and enforce cGMP-compliant SOPs, batch records, and safety procedures\nProvide on-the-floor training, mentorship, and performance feedback to production staff\nMonitor and troubleshoot production activities and equipment, escalating as needed \nPartner with QA and QC to support in-process checks, deviation investigations, and batch record reviews\nMaintain real-time, accurate documentation of manufacturing processes and equipment use\nSupport continuous improvement initiatives to increase reliability and efficiency.\nParticipate in CAPA and deviation investigations related to manufacturing activities\n"},{"text":"Minimum Qualifications","content":"\nB.S. degree required in biology or related field\n2+ years of supervisory or team experience is required \nStrong understanding of aseptic manufacturing practices and clean room operations \n"},{"text":"Preferred Qualifications","content":"\nM.S. degree in biology or related field\nPrior experience in cell therapy or other advanced biologics\nFamiliarity with deviation investigations, CAPAs and change control processes\n"},{"text":"Personal Qualities & Physical Demands","content":"\nAbility to gown and work in clean rooms and Biosafety safety cabinets \nHighly detail oriented with special attention to quality \nDemonstrates strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment \nStrong interpersonal skills and ability to communicate effectively \nAbility to work in a collaborative manner \nAbility to work independently and as part of a team \nHighly tolerant and respectful of all team members \nA sense of humor is always appreciated \nStrong problem-solving skills \nMust be able to remain in a stationary position 50% of the time while in a biosafety cabinet/cleanroom environment which includes wearing a PPE gown \nFollow cleanroom protocols, e.g. no cosmetics including make-up, painted nails, jewelry or piercings, and must disclose any shedding skin condition \nOccasional need to ascend/descend stairs within workspace; job requires standing/walking \n"}],"salaryRange":{"min":75000,"max":100000,"currency":"USD","interval":"per-year-salary"},"salaryDescription":"This position is eligible for shift-differential pay of +5%!
","salaryDescriptionPlain":"This position is eligible for shift-differential pay of +5%!\n","text":"Supervisor, Clinical Manufacturing, 2nd Shift","country":"US","workplaceType":"onsite","opening":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\nWe operate a dedicated clinical manufacturing facility in Sacramento, CA (3400 Business Drive), which has historically served as the foundation for producing our high-precision cell therapy products. This site plays a critical role in advancing our clinical pipeline and ensuring the consistent, reliable supply of therapies for patients participating in our trials.
","openingPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n \nWe operate a dedicated clinical manufacturing facility in Sacramento, CA (3400 Business Drive), which has historically served as the foundation for producing our high-precision cell therapy products. This site plays a critical role in advancing our clinical pipeline and ensuring the consistent, reliable supply of therapies for patients participating in our trials.\n","descriptionBody":"This is a 2nd shift-based position, working on-site Monday through Friday, from 3 pm to 11:30 pm. The Supervisor, Clinical Manufacturing plays a critical role overseeing the production of Orca’s cell therapy products, ensuring adherence to strict quality standards, regulatory requirements and aseptic production techniques. This position works on shift to provide supervision and direction to associates, cell therapy production, oncology to ensure timely and compliant manufacturing.
","descriptionBodyPlain":"This is a 2nd shift-based position, working on-site Monday through Friday, from 3 pm to 11:30 pm. The Supervisor, Clinical Manufacturing plays a critical role overseeing the production of Orca’s cell therapy products, ensuring adherence to strict quality standards, regulatory requirements and aseptic production techniques. This position works on shift to provide supervision and direction to associates, cell therapy production, oncology to ensure timely and compliant manufacturing.\n","hostedUrl":"https://jobs.lever.co/orcabiosystems/7b859745-4187-45d6-84e3-ecb1e3d5780b","applyUrl":"https://jobs.lever.co/orcabiosystems/7b859745-4187-45d6-84e3-ecb1e3d5780b/apply"},{"additionalPlain":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.\n \nWho we are\n \nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.\n \nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.\n \nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.\n \nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.\n \nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.\n \nNotice to staffing firms\n \nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.\n","additional":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
\n
\nWho we are
\n
\nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\nNotice to staffing firms
\n
\nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
","categories":{"commitment":"Regular, Full-Time Employee","department":"Manufacturing","location":"Sacramento, CA","team":"Production","allLocations":["Sacramento, CA"]},"createdAt":1780514275529,"descriptionPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n \nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.\n\n\nThe Supervisor, Commercial Manufacturing plays a critical role overseeing the production of Orca’s cell therapy products, ensuring adherence to strict quality standards, regulatory requirements and aseptic production techniques. This position works on shift to provide supervision and direction to Associates, Cell Therapy Production, Oncology to ensure timely and compliant manufacturing.\n \nDay Shift:\n• 6:00am to 6:30pm or\n• 6:30am to 7:00pm\n \nWork Week Schedule:\n• Sunday, Monday, Tuesday + every other Wednesday or\n• Thursday, Friday, Saturday + every other Wednesday\n","description":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
The Supervisor, Commercial Manufacturing plays a critical role overseeing the production of Orca’s cell therapy products, ensuring adherence to strict quality standards, regulatory requirements and aseptic production techniques. This position works on shift to provide supervision and direction to Associates, Cell Therapy Production, Oncology to ensure timely and compliant manufacturing.
\n
\n\n
Day Shift:
\n
• 6:00am to 6:30pm or
\n
• 6:30am to 7:00pm
\n
\n
\n
Work Week Schedule:
\n
• Sunday, Monday, Tuesday + every other Wednesday or
\n
• Thursday, Friday, Saturday + every other Wednesday
\n
\n
More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
","openingPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n \nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.\n","descriptionBody":"The Supervisor, Commercial Manufacturing plays a critical role overseeing the production of Orca’s cell therapy products, ensuring adherence to strict quality standards, regulatory requirements and aseptic production techniques. This position works on shift to provide supervision and direction to Associates, Cell Therapy Production, Oncology to ensure timely and compliant manufacturing.
\n
\n\n
Day Shift:
\n
• 6:00am to 6:30pm or
\n
• 6:30am to 7:00pm
\n
\n
\n
Work Week Schedule:
\n
• Sunday, Monday, Tuesday + every other Wednesday or
\n
• Thursday, Friday, Saturday + every other Wednesday
\n
\n
The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
\n
\nWho we are
\n
\nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\nNotice to staffing firms
\n
\nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
","categories":{"commitment":"Regular, Full-Time Employee","department":"Manufacturing","location":"Sacramento, CA","team":"Production","allLocations":["Sacramento, CA"]},"createdAt":1751320969850,"descriptionPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n \nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.\n\n\nThe Supervisor, Commercial Manufacturing plays a critical role overseeing the production of Orca’s cell therapy products, ensuring adherence to strict quality standards, regulatory requirements and aseptic production techniques. This position works on shift to provide supervision and direction to Associates, Cell Therapy Production, Oncology to ensure timely and compliant manufacturing.\n \nNight Shift:\n• 6:00pm to 6:30am or\n• 6:30pm to 7:00am\n \nWork Week Schedule:\n• Sunday, Monday, Tuesday + every other Wednesday or\n• Thursday, Friday, Saturday + every other Wednesday\n","description":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
The Supervisor, Commercial Manufacturing plays a critical role overseeing the production of Orca’s cell therapy products, ensuring adherence to strict quality standards, regulatory requirements and aseptic production techniques. This position works on shift to provide supervision and direction to Associates, Cell Therapy Production, Oncology to ensure timely and compliant manufacturing.
\n
\n\n
Night Shift:
\n
• 6:00pm to 6:30am or
\n
• 6:30pm to 7:00am
\n
\n
\n
Work Week Schedule:
\n
• Sunday, Monday, Tuesday + every other Wednesday or
\n
• Thursday, Friday, Saturday + every other Wednesday
\n
\n
This position is eligible for shift-differential pay of +7%!
","salaryDescriptionPlain":"This position is eligible for shift-differential pay of +7%!\n","text":"Supervisor, Commercial Manufacturing - Night Shift","country":"US","workplaceType":"onsite","opening":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
","openingPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n \nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.\n","descriptionBody":"The Supervisor, Commercial Manufacturing plays a critical role overseeing the production of Orca’s cell therapy products, ensuring adherence to strict quality standards, regulatory requirements and aseptic production techniques. This position works on shift to provide supervision and direction to Associates, Cell Therapy Production, Oncology to ensure timely and compliant manufacturing.
\n
\n\n
Night Shift:
\n
• 6:00pm to 6:30am or
\n
• 6:30pm to 7:00am
\n
\n
\n
Work Week Schedule:
\n
• Sunday, Monday, Tuesday + every other Wednesday or
\n
• Thursday, Friday, Saturday + every other Wednesday
\n
\n
The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
\n
\nWho we are
\n
\nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\nNotice to staffing firms
\n
\nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
","categories":{"commitment":"Regular, Full-Time Employee","department":"Manufacturing","location":"Sacramento, CA","team":"Planning, Materials & Procurement","allLocations":["Sacramento, CA"]},"createdAt":1773857695812,"descriptionPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n\n\nThe Supervisor, Materials and Cold Chain Operations - Night Shift is responsible for overseeing daily operations associated with material supply, material handling, cryogenic storage, and cold chain packaging and shipping of cell therapy drug products. \nThis role ensures that GMP-compliant handling, storage, packaging, and distribution of materials and drug products are performed safely, accurately, and in accordance with regulatory requirements, internal procedures, and chain-of-identity/chain-of-custody controls. \nThe supervisor leads a team of material handlers and cryogenic processing/packaging specialists, ensuring operational readiness, inventory control, and timely shipment of critical materials and patient-specific drug products. \nNight Shift Hours worked:\n \n• 10:00 PM – 6:30 AM\n• Coverage: Overnight operations, early morning handoff\n \nWork Week Schedule:\n \n• Monday - Friday\n \nPlease note there will be on call rotation between Day Shift and Night Shift supervisors. This is to ensure coverage for the off hours (3:30pm - 10pm and weekends). \n","description":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\n
The Supervisor, Materials and Cold Chain Operations - Night Shift is responsible for overseeing daily operations associated with material supply, material handling, cryogenic storage, and cold chain packaging and shipping of cell therapy drug products.
\n
\n
This role ensures that GMP-compliant handling, storage, packaging, and distribution of materials and drug products are performed safely, accurately, and in accordance with regulatory requirements, internal procedures, and chain-of-identity/chain-of-custody controls.
\n
\n
The supervisor leads a team of material handlers and cryogenic processing/packaging specialists, ensuring operational readiness, inventory control, and timely shipment of critical materials and patient-specific drug products.
\n
\n
Night Shift Hours worked:
\n
\n
• 10:00 PM – 6:30 AM
\n
\n
• Coverage: Overnight operations, early morning handoff
\n
\n
\n
Work Week Schedule:
\n
\n
• Monday - Friday
\n
\n
Please note there will be on call rotation between Day Shift and Night Shift supervisors. This is to ensure coverage for the off hours (3:30pm - 10pm and weekends).
\n
\n
\n
\n
\n
\n
\n
\n
\n
\n
Cold Chain Management:
\n
\n
\n
\n
\n
\n
\n
\n
\n
\n
\n
\n
\n
\n
\n
\n
\n
\n
\n- Bachelor’s degree in operations management, or supply chain plus 2 years of supervisory experience or
\n\n
\n
\n
\n
\n
\n- \n
Operational leadership
\n \n\n
\n
\n
\n
\n
\n
\n
\n
\n
\n- \n
Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
\n \n\n
\n
\n
\n- \n
Must meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.
\n \n\n
\n
\n
\n\n
\n\n- \n
Ability to lift 25 lbs
\n \n\n\n\n
\n
\n
\n
This position works onsite and does not require travel.
"}],"salaryRange":{"min":75000,"max":95000,"currency":"USD","interval":"per-year-salary"},"text":"Supervisor, Materials and Cold Chain Operations - Night Shift","country":"US","workplaceType":"onsite","opening":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n
The Supervisor, Materials and Cold Chain Operations - Night Shift is responsible for overseeing daily operations associated with material supply, material handling, cryogenic storage, and cold chain packaging and shipping of cell therapy drug products.
\n
\n
This role ensures that GMP-compliant handling, storage, packaging, and distribution of materials and drug products are performed safely, accurately, and in accordance with regulatory requirements, internal procedures, and chain-of-identity/chain-of-custody controls.
\n
\n
The supervisor leads a team of material handlers and cryogenic processing/packaging specialists, ensuring operational readiness, inventory control, and timely shipment of critical materials and patient-specific drug products.
\n
\n
Night Shift Hours worked:
\n
\n
• 10:00 PM – 6:30 AM
\n
\n
• Coverage: Overnight operations, early morning handoff
\n
\n
\n
Work Week Schedule:
\n
\n
• Monday - Friday
\n
\n
Please note there will be on call rotation between Day Shift and Night Shift supervisors. This is to ensure coverage for the off hours (3:30pm - 10pm and weekends).
\n
\n
The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
\n
\nWho we are
\n
\nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\nNotice to staffing firms
\n
\nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
","categories":{"commitment":"Regular, Full-Time Employee","department":"Quality","location":"Sacramento, CA","team":"Quality Control","allLocations":["Sacramento, CA"]},"createdAt":1772840745405,"descriptionPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n \nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.\n\n\nThe Supervisor, Quality Control (QC) is responsible for overseeing daily operations within the QC laboratory to ensure compliance with regulatory standards, internal procedures, and quality expectations. This position plays a critical role in maintaining data integrity through audit trail reviews, leading investigations of out-of-specification (OOS) results and deviations, and ensuring the lab remains in a consistent state of inspection readiness. \n \nWe are multiple positions across the following schedules:\n \nDay Shift:\n• 6:00am to 6:30pm or\n• 6:30am to 7:00pm\n \nNight Shift:\n• 6:00pm to 6:30am or\n• 6:30pm to 7:00am\n \nWork Week Schedule:\n• Sunday, Monday, Tuesday + every other Wednesday or\n• Thursday, Friday, Saturday + every other Wednesday\n","description":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
The Supervisor, Quality Control (QC) is responsible for overseeing daily operations within the QC laboratory to ensure compliance with regulatory standards, internal procedures, and quality expectations. This position plays a critical role in maintaining data integrity through audit trail reviews, leading investigations of out-of-specification (OOS) results and deviations, and ensuring the lab remains in a consistent state of inspection readiness.
\n
\nWe are multiple positions across the following schedules:
\n
\nDay Shift:
\n• 6:00am to 6:30pm or
\n• 6:30am to 7:00pm
\n
\nNight Shift:
\n• 6:00pm to 6:30am or
\n• 6:30pm to 7:00am
\n
\nWork Week Schedule:
\n• Sunday, Monday, Tuesday + every other Wednesday or
\n• Thursday, Friday, Saturday + every other Wednesday
","id":"1ad17931-122b-4079-bcde-496b5347be76","lists":[{"text":"Physical Demands","content":"\nProduction Associate Roles: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.\nMost roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.\n"},{"text":"Work Conditions","content":"\nMany roles must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video-based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs.\n"},{"text":"Essential Duties & Key Responsibilities","content":"\nLab work and supervisor roles: Lead routine quality control testing on raw materials, process intermediates, and final cell therapy products. Supervise the QC team, supporting data verification, leading investigations, prioritizing tasks, and collaborating with other teams. Perform tests, ensure compliance, maintain the lab, prepare reagents, aliquot samples, assist with assay transfer/validation, train staff, and manage supplies.\nData Integrity and Audit Trail Review: Ensure GMP compliance by conducting audit trail reviews, identifying data integrity issues, and ensuring proper documentation. Lead and document QC testing results, and assist with preparing and reviewing batch records, SOPs, and related documentation to ensure adherence to cGMP regulations.\nInvestigations and CAPA: Oversee Quality System investigations into OOS results, atypical findings, and lab deviations. Ensure root cause analysis, documentation, and implementation of CAPAs, collaborating with cross-functional teams to resolve quality issues.\nLab Inspection Readiness: Monitor lab conditions to ensure compliance with cGMP and FDA/EMA regulations, maintaining documentation, equipment logs, and records for inspection readiness. Lead preparation activities for internal and external audits, including document reviews and mock audits.\nTeam Leadership and Oversight: Manage and support a team of QC analysts, overseeing scheduling, training, and performance evaluations. Provide technical guidance and mentorship to ensure high-quality, compliant practices.\nDocumentation and Reporting: Review and approve analytical data, protocols, and reports for accuracy and compliance. Maintain metrics for lab performance, deviations, investigations, and audit trail reviews.\nIdentify opportunities to improve lab operations, workflow efficiency, and compliance practices, and actively participate in revising and developing SOPs and policies.\nCollaborate with cross-functional teams to ensure that external requests and activities align with site priorities.\nPerform other duties as requested by supervisor/manager to support QualityStay current with industry regulations, standards, and best practices related to quality control.\nStay current with industry regulations, standards, and best practices related to quality control.\n\n
"},{"text":"Minimum Qualifications","content":"\nBachelor’s degree in Chemistry, Biology, or a related scientific discipline (Master’s degree preferred).\nMinimum of 5 years of experience in a GMP-regulated QC laboratory, with at least 2 years in a supervisory or lead role.\nStrong knowledge of cGMP, FDA, and ICH guidelines.\nProven experience conducting audit trail reviews and leading laboratory investigations.\nExcellent organizational, analytical, and communication skills.\nAbility to manage multiple priorities and work in a fast-paced environment.\n"}],"salaryRange":{"min":70000,"max":110000,"currency":"USD","interval":"per-year-salary"},"salaryDescription":"Night shift is eligible for a shift differential pay of +7%.
","salaryDescriptionPlain":"Night shift is eligible for a shift differential pay of +7%.\n","text":"Supervisor, Quality Control","country":"US","workplaceType":"onsite","opening":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
","openingPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n \nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.\n","descriptionBody":"The Supervisor, Quality Control (QC) is responsible for overseeing daily operations within the QC laboratory to ensure compliance with regulatory standards, internal procedures, and quality expectations. This position plays a critical role in maintaining data integrity through audit trail reviews, leading investigations of out-of-specification (OOS) results and deviations, and ensuring the lab remains in a consistent state of inspection readiness.
\n
\nWe are multiple positions across the following schedules:
\n
\nDay Shift:
\n• 6:00am to 6:30pm or
\n• 6:30am to 7:00pm
\n
\nNight Shift:
\n• 6:00pm to 6:30am or
\n• 6:30pm to 7:00am
\n
\nWork Week Schedule:
\n• Sunday, Monday, Tuesday + every other Wednesday or
\n• Thursday, Friday, Saturday + every other Wednesday
","descriptionBodyPlain":"The Supervisor, Quality Control (QC) is responsible for overseeing daily operations within the QC laboratory to ensure compliance with regulatory standards, internal procedures, and quality expectations. This position plays a critical role in maintaining data integrity through audit trail reviews, leading investigations of out-of-specification (OOS) results and deviations, and ensuring the lab remains in a consistent state of inspection readiness. \n \nWe are multiple positions across the following schedules:\n \nDay Shift:\n• 6:00am to 6:30pm or\n• 6:30am to 7:00pm\n \nNight Shift:\n• 6:00pm to 6:30am or\n• 6:30pm to 7:00am\n \nWork Week Schedule:\n• Sunday, Monday, Tuesday + every other Wednesday or\n• Thursday, Friday, Saturday + every other Wednesday\n","hostedUrl":"https://jobs.lever.co/orcabiosystems/1ad17931-122b-4079-bcde-496b5347be76","applyUrl":"https://jobs.lever.co/orcabiosystems/1ad17931-122b-4079-bcde-496b5347be76/apply"},{"additionalPlain":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.\n \nWho we are\n \nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.\n \nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.\n \nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.\n \nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.\n \nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.\n \nNotice to staffing firms\n \nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.\n","additional":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
\n
\nWho we are
\n
\nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\nNotice to staffing firms
\n
\nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
","categories":{"commitment":"Regular, Full-Time Employee","department":"Quality","location":"Sacramento, CA","team":"Quality Assurance","allLocations":["Sacramento, CA"]},"createdAt":1773876566085,"descriptionPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n \nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.\n\n\nThe Technician, Quality Assurance plays a critical role in supporting the production of Orca Bio’s life-saving cell therapy products by ensuring adherence to strict quality standards, cGMP compliance, and real-time production support. Reporting into the Quality Assurance leadership team, this position provides on-the-floor QA oversight, conducts real-time record and documentation review, and partners with manufacturing and technical teams to identify and resolve issues. The role collaborates closely with Manufacturing, Quality Control (QC), and other Quality functions to maintain seamless operations in a highly regulated environment.\n \nNight Shift Hours Worked:\n• 6:00pm to 6:30am or\n• 6:30pm to 7:00am\n \nWork Week Schedule:\n• Sunday, Monday, Tuesday + every other Wednesday or\n• Thursday, Friday, Saturday + every other Wednesday\n","description":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
The Technician, Quality Assurance plays a critical role in supporting the production of Orca Bio’s life-saving cell therapy products by ensuring adherence to strict quality standards, cGMP compliance, and real-time production support. Reporting into the Quality Assurance leadership team, this position provides on-the-floor QA oversight, conducts real-time record and documentation review, and partners with manufacturing and technical teams to identify and resolve issues. The role collaborates closely with Manufacturing, Quality Control (QC), and other Quality functions to maintain seamless operations in a highly regulated environment.
\n
\n\n
Night Shift Hours Worked:
\n
• 6:00pm to 6:30am or
\n
• 6:30pm to 7:00am
\n
\n
Work Week Schedule:
\n
• Sunday, Monday, Tuesday + every other Wednesday or
\n
• Thursday, Friday, Saturday + every other Wednesday
\n
\n
\n- Ability to wear cleanroom gowning and adhere to cleanroom entry and gowning requirements
\n- Demonstrated ability to identify and support resolution of technical issues
\n- Familiarity with cGMP regulations and documentation practices
\n- Proven experience collaborating in cross-functional or project teams
\n- Strong attention to detail and ability to follow QA processes and escalation pathways
\n\n
Base hourly pay range: $24–$26. The annualized earnings range above reflects estimated scheduled overtime and a +10% night shift differential. Total compensation will vary based on assigned shift, overtime worked, and applicable differentials.
","salaryDescriptionPlain":"Base hourly pay range: $24–$26. The annualized earnings range above reflects estimated scheduled overtime and a +10% night shift differential. Total compensation will vary based on assigned shift, overtime worked, and applicable differentials.\n","text":"Technician, Quality Assurance - Night Shift","country":"US","workplaceType":"onsite","opening":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
","openingPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n \nWe have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.\n","descriptionBody":"The Technician, Quality Assurance plays a critical role in supporting the production of Orca Bio’s life-saving cell therapy products by ensuring adherence to strict quality standards, cGMP compliance, and real-time production support. Reporting into the Quality Assurance leadership team, this position provides on-the-floor QA oversight, conducts real-time record and documentation review, and partners with manufacturing and technical teams to identify and resolve issues. The role collaborates closely with Manufacturing, Quality Control (QC), and other Quality functions to maintain seamless operations in a highly regulated environment.
\n
\n\n
Night Shift Hours Worked:
\n
• 6:00pm to 6:30am or
\n
• 6:30pm to 7:00am
\n
\n
Work Week Schedule:
\n
• Sunday, Monday, Tuesday + every other Wednesday or
\n
• Thursday, Friday, Saturday + every other Wednesday
\n
The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
\n
\nWho we are
\n
\nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\nNotice to staffing firms
\n
\nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
","categories":{"commitment":"Regular, Full-Time Employee","department":"Quality","location":"Sacramento, CA","team":"Quality Control","allLocations":["Sacramento, CA"]},"createdAt":1776276729148,"descriptionPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n \nWe operate a dedicated clinical manufacturing facility in Sacramento, CA (3400 Business Drive), which has historically served as the foundation for producing our high-precision cell therapy products. This site plays a critical role in advancing our clinical pipeline and ensuring the consistent, reliable supply of therapies for patients participating in our trials.\n\n\nThe Technician, Quality Control conducts routine and non-routine testing to ensure the highest quality standards in our cell therapy manufacturing facility. Your work will play a crucial role in maintaining the integrity and safety of our cell therapy products.\n \n1st Shift Hours Worked:\n• 7:00am to 3:30pm\n \nWork Week Schedule:\n• Monday through Friday\n","description":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\nWe operate a dedicated clinical manufacturing facility in Sacramento, CA (3400 Business Drive), which has historically served as the foundation for producing our high-precision cell therapy products. This site plays a critical role in advancing our clinical pipeline and ensuring the consistent, reliable supply of therapies for patients participating in our trials.
The Technician, Quality Control conducts routine and non-routine testing to ensure the highest quality standards in our cell therapy manufacturing facility. Your work will play a crucial role in maintaining the integrity and safety of our cell therapy products.
\n
\n\n
1st Shift Hours Worked:
\n
• 7:00am to 3:30pm
\n
\n
Work Week Schedule:
\n
• Monday through Friday
\n
More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
\nWe operate a dedicated clinical manufacturing facility in Sacramento, CA (3400 Business Drive), which has historically served as the foundation for producing our high-precision cell therapy products. This site plays a critical role in advancing our clinical pipeline and ensuring the consistent, reliable supply of therapies for patients participating in our trials.
","openingPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n \nWe operate a dedicated clinical manufacturing facility in Sacramento, CA (3400 Business Drive), which has historically served as the foundation for producing our high-precision cell therapy products. This site plays a critical role in advancing our clinical pipeline and ensuring the consistent, reliable supply of therapies for patients participating in our trials.\n","descriptionBody":"The Technician, Quality Control conducts routine and non-routine testing to ensure the highest quality standards in our cell therapy manufacturing facility. Your work will play a crucial role in maintaining the integrity and safety of our cell therapy products.
\n
\n\n
1st Shift Hours Worked:
\n
• 7:00am to 3:30pm
\n
\n
Work Week Schedule:
\n
• Monday through Friday
\n
The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
\n
\nWho we are
\n
\nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\nNotice to staffing firms
\n
\nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
","categories":{"commitment":"Regular, Full-Time Employee","department":"Quality","location":"Sacramento, CA","team":"Quality Control","allLocations":["Sacramento, CA"]},"createdAt":1779990582216,"descriptionPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n\n\nThe Technician, Quality Control - Night Shift conducts routine and non-routine testing to ensure the highest quality standards in our cell therapy manufacturing facility. Your work will play a crucial role in maintaining the integrity and safety of our cell therapy products.\n \nNight Shift Hours Worked:\n• 6:00pm to 6:30am or\n• 6:30pm to 7:00am\n \nWork Week Schedule:\n• Sunday, Monday, Tuesday + every other Wednesday or\n• Thursday, Friday, Saturday + every other Wednesday \n","description":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
The Technician, Quality Control - Day Shift conducts routine and non-routine testing to ensure the highest quality standards in our cell therapy manufacturing facility. Your work will play a crucial role in maintaining the integrity and safety of our cell therapy products.
\n
\nDay Shift Hours Worked:
\n• 6:00am to 6:30pm or
\n• 6:30am to 7:00pm
\n
\nWork Week Schedule:
\n• Sunday, Monday, Tuesday + every other Wednesday or
\n• Thursday, Friday, Saturday + every other Wednesday
","id":"41b76854-473e-4785-9a22-17b34297d7fa","lists":[{"text":"Physical Demands","content":"\nProduction Associate Roles: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.\nMust be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.\n"},{"text":"Work Conditions","content":"\nMust be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.\nMust be comfortable regularly participating in video-based meetings.\nMay be required to work scheduled overtime, weekends, or holidays based on business needs.\n"},{"text":"Job Duties & Key Responsibilities","content":"\nPerform a range of basic to moderately complex analytical tests following cGMP guidelines\nTest routine and non-routine samples; document results with accuracy and compliance\nMaintain, calibrate, and troubleshoot lab equipment to ensure functionality\nPrepare reagents and aliquot samples, including aseptic techniques when needed\nMonitor and maintain inventory of lab supplies\nSupport assay transfers, validations, and equipment qualifications\nAliquot samples as required, including aseptic aliquoting\nActively participate in group and project teamwork; project and process improvements\nWork cross-functionally with Manufacturing, QC, and QA to resolve issues and implement corrective actions\nFollow all cGMP documentation and procedural standards\nPerform additional duties as assigned to support the Quality team\n"},{"text":"Minimum Qualifications","content":"\nA.S. or B.S. in a relevant scientific discipline (biology, microbiology, etc.) required\nHigh attention to detail and a commitment to data integrity\nStrong organizational, communication, and problem-solving skills\nAbility to work both independently and collaboratively in a fast-paced, regulated setting\nFlexible and responsive to changing priorities and team needs\nPreferred: Experience with analytical assays (e.g., flow cytometry, ELISA, PCR)\nPreferred: Familiarity with aseptic technique in a GMP or biotech setting\n"}],"salaryRange":{"min":59514,"max":64474,"currency":"USD","interval":"per-year-salary"},"salaryDescription":"Base hourly pay range: $24–$26. The annualized earnings range above reflects estimated scheduled overtime. Total compensation will vary based on assigned shift, overtime worked, and applicable differentials.
","salaryDescriptionPlain":"Base hourly pay range: $24–$26. The annualized earnings range above reflects estimated scheduled overtime and a +10% night shift differential. Total compensation will vary based on assigned shift, overtime worked, and applicable differentials.\n","text":"Technician, Quality Control - Day Shift","country":"US","workplaceType":"onsite","opening":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.The Technician, Quality Control - Day Shift conducts routine and non-routine testing to ensure the highest quality standards in our cell therapy manufacturing facility. Your work will play a crucial role in maintaining the integrity and safety of our cell therapy products.
\n
\nDay Shift Hours Worked:
\n• 6:00am to 6:30pm or
\n• 6:30am to 7:00pm
\n
\nWork Week Schedule:
\n• Sunday, Monday, Tuesday + every other Wednesday or
\n• Thursday, Friday, Saturday + every other Wednesday
","descriptionBodyPlain":"The Technician, Quality Control - Night Shift conducts routine and non-routine testing to ensure the highest quality standards in our cell therapy manufacturing facility. Your work will play a crucial role in maintaining the integrity and safety of our cell therapy products.\n \nNight Shift Hours Worked:\n• 6:00pm to 6:30am or\n• 6:30pm to 7:00am\n \nWork Week Schedule:\n• Sunday, Monday, Tuesday + every other Wednesday or\n• Thursday, Friday, Saturday + every other Wednesday \n","hostedUrl":"https://jobs.lever.co/orcabiosystems/41b76854-473e-4785-9a22-17b34297d7fa","applyUrl":"https://jobs.lever.co/orcabiosystems/41b76854-473e-4785-9a22-17b34297d7fa/apply"},{"additionalPlain":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.\n \nWho we are\n \nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.\n \nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.\n \nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.\n \nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.\n \nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.\n \nNotice to staffing firms\n \nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.\n","additional":"The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
\n
\nWho we are
\n
\nWe are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
\n
\nWe live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
\n
\nWe innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
\n
\nWe maintain a start-up culture of camaraderie and leadership by example, regardless of title.
\n
\nWe’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
\n
\nNotice to staffing firms
\n
\nOrca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
","categories":{"commitment":"Regular, Full-Time Employee","department":"Quality","location":"Sacramento, CA","team":"Quality Control","allLocations":["Sacramento, CA"]},"createdAt":1772842009382,"descriptionPlain":"More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.\n\n\nThe Technician, Quality Control - Night Shift conducts routine and non-routine testing to ensure the highest quality standards in our cell therapy manufacturing facility. Your work will play a crucial role in maintaining the integrity and safety of our cell therapy products.\n \nNight Shift Hours Worked:\n• 6:00pm to 6:30am or\n• 6:30pm to 7:00am\n \nWork Week Schedule:\n• Sunday, Monday, Tuesday + every other Wednesday or\n• Thursday, Friday, Saturday + every other Wednesday \n","description":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
The Technician, Quality Control - Night Shift conducts routine and non-routine testing to ensure the highest quality standards in our cell therapy manufacturing facility. Your work will play a crucial role in maintaining the integrity and safety of our cell therapy products.
\n
\nNight Shift Hours Worked:
\n• 6:00pm to 6:30am or
\n• 6:30pm to 7:00am
\n
\nWork Week Schedule:
\n• Sunday, Monday, Tuesday + every other Wednesday or
\n• Thursday, Friday, Saturday + every other Wednesday
","id":"4fd0b858-206d-41e3-aebc-724d9e858b0b","lists":[{"text":"Physical Demands","content":"\nProduction Associate Roles: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.\nMust be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.\n"},{"text":"Work Conditions","content":"\nMust be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.\nMust be comfortable regularly participating in video-based meetings.\nMay be required to work scheduled overtime, weekends, or holidays based on business needs.\n"},{"text":"Job Duties & Key Responsibilities","content":"\nPerform a range of basic to moderately complex analytical tests following cGMP guidelines\nTest routine and non-routine samples; document results with accuracy and compliance\nMaintain, calibrate, and troubleshoot lab equipment to ensure functionality\nPrepare reagents and aliquot samples, including aseptic techniques when needed\nMonitor and maintain inventory of lab supplies\nSupport assay transfers, validations, and equipment qualifications\nAliquot samples as required, including aseptic aliquoting\nActively participate in group and project teamwork; project and process improvements\nWork cross-functionally with Manufacturing, QC, and QA to resolve issues and implement corrective actions\nFollow all cGMP documentation and procedural standards\nPerform additional duties as assigned to support the Quality team\n"},{"text":"Minimum Qualifications","content":"\nA.S. or B.S. in a relevant scientific discipline (biology, microbiology, etc.) required\nHigh attention to detail and a commitment to data integrity\nStrong organizational, communication, and problem-solving skills\nAbility to work both independently and collaboratively in a fast-paced, regulated setting\nFlexible and responsive to changing priorities and team needs\nPreferred: Experience with analytical assays (e.g., flow cytometry, ELISA, PCR)\nPreferred: Familiarity with aseptic technique in a GMP or biotech setting\n"}],"salaryRange":{"min":65465,"max":70921,"currency":"USD","interval":"per-year-salary"},"salaryDescription":"Base hourly pay range: $24–$26. The annualized earnings range above reflects estimated scheduled overtime and a +10% night shift differential. Total compensation will vary based on assigned shift, overtime worked, and applicable differentials.
","salaryDescriptionPlain":"Base hourly pay range: $24–$26. The annualized earnings range above reflects estimated scheduled overtime and a +10% night shift differential. Total compensation will vary based on assigned shift, overtime worked, and applicable differentials.\n","text":"Technician, Quality Control - Night Shift","country":"US","workplaceType":"onsite","opening":"More than one million people in the United States today are fighting blood cancer. While a traditional
allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.
With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.The Technician, Quality Control - Night Shift conducts routine and non-routine testing to ensure the highest quality standards in our cell therapy manufacturing facility. Your work will play a crucial role in maintaining the integrity and safety of our cell therapy products.
\n
\nNight Shift Hours Worked:
\n• 6:00pm to 6:30am or
\n• 6:30pm to 7:00am
\n
\nWork Week Schedule:
\n• Sunday, Monday, Tuesday + every other Wednesday or
\n• Thursday, Friday, Saturday + every other Wednesday
","descriptionBodyPlain":"The Technician, Quality Control - Night Shift conducts routine and non-routine testing to ensure the highest quality standards in our cell therapy manufacturing facility. Your work will play a crucial role in maintaining the integrity and safety of our cell therapy products.\n \nNight Shift Hours Worked:\n• 6:00pm to 6:30am or\n• 6:30pm to 7:00am\n \nWork Week Schedule:\n• Sunday, Monday, Tuesday + every other Wednesday or\n• Thursday, Friday, Saturday + every other Wednesday \n","hostedUrl":"https://jobs.lever.co/orcabiosystems/4fd0b858-206d-41e3-aebc-724d9e858b0b","applyUrl":"https://jobs.lever.co/orcabiosystems/4fd0b858-206d-41e3-aebc-724d9e858b0b/apply"}]