[{"additional":"","additionalPlain":"","categories":{"commitment":"Full-Time","location":"Greater Madison, WI Area","team":"Production","allLocations":["Greater Madison, WI Area"]},"createdAt":1776261859725,"descriptionPlain":"About eGenesis\neGenesis is a clinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Company’s proprietary genome engineering platform enables extensive, multiplex gene edits to remove key biological barriers, add protective human transgenes, and inactivate endogenous retroviruses. EGEN-2784, a genetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in a multi-patient Expanded Access study at MGH. eGenesis is headquartered in Cambridge, MA. \n\n\nPOSITION SUMMARY\nThe Animal Care Technician shall provide animal care and upkeep animal areas in accordance with the company standard operating procedure. This position will assist other personnel in all animal-related projects and procedures. As part of the broader Animal Care Team, you will collaborate with Farm Operations Team members to ensure all farm activities are completed according to eGenesis standards and guidelines. This position will be expected to be involved in a weekend rotating shift schedule.\n","description":"About eGenesis
eGenesis is a clinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Company’s proprietary genome engineering platform enables extensive, multiplex gene edits to remove key biological barriers, add protective human transgenes, and inactivate endogenous retroviruses. EGEN-2784, a genetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in a multi-patient Expanded Access study at MGH. eGenesis is headquartered in Cambridge, MA.
POSITION SUMMARY
\nThe Animal Care Technician shall provide animal care and upkeep animal areas in accordance with the company standard operating procedure. This position will assist other personnel in all animal-related projects and procedures. As part of the broader Animal Care Team, you will collaborate with Farm Operations Team members to ensure all farm activities are completed according to eGenesis standards and guidelines. This position will be expected to be involved in a weekend rotating shift schedule.
","id":"14dbdfcd-07a8-4d13-9ff7-434694de73f0","lists":[{"text":"PRIMARY RESPONSIBILITIES","content":"\nFeeding and cleaning of all animals and housing facilities\nClosely observe animals when working with them and report any unusual conditions immediately to Vet Staff/Direct Supervisor\nAssist in safe animal handling and movements\nMaintain high standard of animal care and welfare\nMaintenance of animal related equipment and facilities\nResponsible for maintaining all aspects relative to research animal care, health, and treatment\nFollow instructions and recommendations for animal treatments in accordance with on-site Vet Staff direction\nSupport Vet Staff with the preparation of animals undergoing surgeries\nResponsible for maintaining and keeping health and herd management records\nPerform estrus synchronization, injection/administration of hormones, and heat checking/estrus detection\nPromote and adhere to safety in the workplace by following safe work practices and enforcing health and safety regulations\nAdhere to eGenesis biosecurity requirements\n"},{"text":"BASIC QUALIFICATIONS","content":"\n0-3+ years of hands-on livestock handling or relevant animal research experience\nHighschool diploma or equivalent, Bachelors degree or Masters degree in relevant animal science field\nWorking knowledge of farm equipment is beneficial but not required\nMust not have any other interaction with pigs outside of the company\nProficient in Microsoft Office Suite is beneficial but not required\nTime management skills and the ability to prioritize work\nAttention to detail and problem-solving skills\nExcellent communication\nStrong organizational skills with the ability to multi-task\nKnowledge of swine operations is beneficial but not required\n"},{"text":"PHYSICAL DEMANDS AND WORK ENVIRONMENT","content":"While performing the duties of this job, the employee is regularly required to work in different environments, including farm, shop, office, and animal husbandry environments in varying weather conditions. The employee frequently is required to be walking, stooping, climbing, and crouching. Employees are regularly expected to lift objects 30-60lbs multiple times throughout the day. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust to focus.
"},{"text":"TOTAL REWARDS","content":"\n
eGenesis is proud to offer competitive compensation including base pay and annual bonus. We take great care in offering our employees excellent benefits including:
\n\n
Medical insurance (90% company paid)\n
Dental insurance (90% company paid)\n
Vision insurance (100% company paid)\n
401k with a company match\n
Paid time off and paid sick time\n
Paid holidays\n\n
About eGenesis
eGenesis is a clinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Company’s proprietary genome engineering platform enables extensive, multiplex gene edits to remove key biological barriers, add protective human transgenes, and inactivate endogenous retroviruses. EGEN-2784, a genetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in a multi-patient Expanded Access study at MGH. eGenesis is headquartered in Cambridge, MA.
","openingPlain":"About eGenesis\neGenesis is a clinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Company’s proprietary genome engineering platform enables extensive, multiplex gene edits to remove key biological barriers, add protective human transgenes, and inactivate endogenous retroviruses. EGEN-2784, a genetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in a multi-patient Expanded Access study at MGH. eGenesis is headquartered in Cambridge, MA. \n","descriptionBody":"POSITION SUMMARY
\nThe Animal Care Technician shall provide animal care and upkeep animal areas in accordance with the company standard operating procedure. This position will assist other personnel in all animal-related projects and procedures. As part of the broader Animal Care Team, you will collaborate with Farm Operations Team members to ensure all farm activities are completed according to eGenesis standards and guidelines. This position will be expected to be involved in a weekend rotating shift schedule.
","descriptionBodyPlain":"POSITION SUMMARY\nThe Animal Care Technician shall provide animal care and upkeep animal areas in accordance with the company standard operating procedure. This position will assist other personnel in all animal-related projects and procedures. As part of the broader Animal Care Team, you will collaborate with Farm Operations Team members to ensure all farm activities are completed according to eGenesis standards and guidelines. This position will be expected to be involved in a weekend rotating shift schedule.\n","hostedUrl":"https://jobs.lever.co/egenesisbio/14dbdfcd-07a8-4d13-9ff7-434694de73f0","applyUrl":"https://jobs.lever.co/egenesisbio/14dbdfcd-07a8-4d13-9ff7-434694de73f0/apply"},{"additional":"","additionalPlain":"","categories":{"commitment":"Full-Time","location":"Northwest, Indiana","team":"Production","allLocations":["Northwest, Indiana"]},"createdAt":1779216301005,"descriptionPlain":"About eGenesis\neGenesis is a clinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Company’s proprietary genome engineering platform enables extensive, multiplex gene edits to remove key biological barriers, add protective human transgenes, and inactivate endogenous retroviruses. EGEN-2784, a genetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in a multi-patient Expanded Access study at MGH. eGenesis is headquartered in Cambridge, MA. \n\n\nPOSITION SUMMARY\nThe Animal Care Technician shall provide animal care and upkeep animal areas in accordance with the company standard operating procedure. This position will assist other personnel in all animal-related projects and procedures. As part of the broader Animal Care Team, you will collaborate with Farm Operations Team members to ensure all farm activities are completed according to eGenesis standards and guidelines. This position will be expected to be involved in a weekend rotating shift schedule.\n","description":"About eGenesis
eGenesis is a clinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Company’s proprietary genome engineering platform enables extensive, multiplex gene edits to remove key biological barriers, add protective human transgenes, and inactivate endogenous retroviruses. EGEN-2784, a genetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in a multi-patient Expanded Access study at MGH. eGenesis is headquartered in Cambridge, MA.
POSITION SUMMARY
\nThe Animal Care Technician shall provide animal care and upkeep animal areas in accordance with the company standard operating procedure. This position will assist other personnel in all animal-related projects and procedures. As part of the broader Animal Care Team, you will collaborate with Farm Operations Team members to ensure all farm activities are completed according to eGenesis standards and guidelines. This position will be expected to be involved in a weekend rotating shift schedule.
","id":"cd8c659b-b75f-4e68-88dd-0df79e686b69","lists":[{"text":"PRIMARY RESPONSIBILITIES","content":"\nFeeding and cleaning of all animals and housing facilities\nClosely observe animals when working with them and report any unusual conditions immediately to Vet Staff/Direct Supervisor\nAssist in safe animal handling and movements\nMaintain high standard of animal care and welfare\nMaintenance of animal related equipment and facilities\nResponsible for maintaining all aspects relative to research animal care, health, and treatment\nFollow instructions and recommendations for animal treatments in accordance with on-site Vet Staff direction\nSupport Vet Staff with the preparation of animals undergoing surgeries\nResponsible for maintaining and keeping health and herd management records\nPerform estrus synchronization, injection/administration of hormones, and heat checking/estrus detection\nPromote and adhere to safety in the workplace by following safe work practices and enforcing health and safety regulations\nAdhere to eGenesis biosecurity requirements\n"},{"text":"BASIC QUALIFICATIONS","content":"\n0-3+ years of hands-on livestock handling or relevant animal research experience\nHighschool diploma or equivalent, Bachelors degree or Masters degree in relevant animal science field\nWorking knowledge of farm equipment is beneficial but not required\nMust not have any other interaction with pigs outside of the company\nProficient in Microsoft Office Suite is beneficial but not required\nTime management skills and the ability to prioritize work\nAttention to detail and problem-solving skills\nExcellent communication\nStrong organizational skills with the ability to multi-task\nKnowledge of swine operations is beneficial but not required\n"},{"text":"PHYSICAL DEMANDS AND WORK ENVIRONMENT","content":"While performing the duties of this job, the employee is regularly required to work in different environments, including farm, shop, office, and animal husbandry environments in varying weather conditions. The employee frequently is required to be walking, stooping, climbing, and crouching. Employees are regularly expected to lift objects 30-60lbs multiple times throughout the day. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust to focus.
"},{"text":"TOTAL REWARDS","content":"\n
eGenesis is proud to offer competitive compensation including base pay and annual bonus. We take great care in offering our employees excellent benefits including:
\n\n
Medical insurance (80% company paid)\n
Dental insurance (80% company paid)\n
Vision insurance (100% company paid)\n
401k with a company match\n
Paid time off and paid sick time\n
Paid holidays\n\n
About eGenesis
eGenesis is a clinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Company’s proprietary genome engineering platform enables extensive, multiplex gene edits to remove key biological barriers, add protective human transgenes, and inactivate endogenous retroviruses. EGEN-2784, a genetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in a multi-patient Expanded Access study at MGH. eGenesis is headquartered in Cambridge, MA.
","openingPlain":"About eGenesis\neGenesis is a clinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Company’s proprietary genome engineering platform enables extensive, multiplex gene edits to remove key biological barriers, add protective human transgenes, and inactivate endogenous retroviruses. EGEN-2784, a genetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in a multi-patient Expanded Access study at MGH. eGenesis is headquartered in Cambridge, MA. \n","descriptionBody":"POSITION SUMMARY
\nThe Animal Care Technician shall provide animal care and upkeep animal areas in accordance with the company standard operating procedure. This position will assist other personnel in all animal-related projects and procedures. As part of the broader Animal Care Team, you will collaborate with Farm Operations Team members to ensure all farm activities are completed according to eGenesis standards and guidelines. This position will be expected to be involved in a weekend rotating shift schedule.
","descriptionBodyPlain":"POSITION SUMMARY\nThe Animal Care Technician shall provide animal care and upkeep animal areas in accordance with the company standard operating procedure. This position will assist other personnel in all animal-related projects and procedures. As part of the broader Animal Care Team, you will collaborate with Farm Operations Team members to ensure all farm activities are completed according to eGenesis standards and guidelines. This position will be expected to be involved in a weekend rotating shift schedule.\n","hostedUrl":"https://jobs.lever.co/egenesisbio/cd8c659b-b75f-4e68-88dd-0df79e686b69","applyUrl":"https://jobs.lever.co/egenesisbio/cd8c659b-b75f-4e68-88dd-0df79e686b69/apply"},{"additionalPlain":"PHYSICAL DEMANDS\nWhile performing the duties of this position, the employee is regularly required to talk or hear. The employee frequently is required to sit, stand, walk, reach with hands or arms, lift, and operate a computer. Specific vision abilities required by this position include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust to focus. The employee frequently is required to lift laboratory supplies and equipment within the daily routine. The employee will be required to handle and work with large animals on a daily basis. \n \nWORK ENVIRONMENT\nThis position will be required to shower-in into the animal facility to perform the required tasks. This position operates in multiple environments, including office, laboratory, and animal husbandry environment. This role routinely uses standard office equipment such as computers, phones, copy machines, filing cabinets, and fax machines. \n","additional":"PHYSICAL DEMANDS
\nWhile performing the duties of this position, the employee is regularly required to talk or hear. The employee frequently is required to sit, stand, walk, reach with hands or arms, lift, and operate a computer. Specific vision abilities required by this position include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust to focus. The employee frequently is required to lift laboratory supplies and equipment within the daily routine. The employee will be required to handle and work with large animals on a daily basis.
\n
\nWORK ENVIRONMENT
\nThis position will be required to shower-in into the animal facility to perform the required tasks. This position operates in multiple environments, including office, laboratory, and animal husbandry environment. This role routinely uses standard office equipment such as computers, phones, copy machines, filing cabinets, and fax machines.
","categories":{"commitment":"Full-Time","location":"Northwest, Indiana","team":"Production","allLocations":["Northwest, Indiana"]},"createdAt":1770930503783,"descriptionPlain":"About eGenesis\neGenesis is a clinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Company’s proprietary genome engineering platform enables extensive, multiplex gene edits to remove key biological barriers, add protective human transgenes, and inactivate endogenous retroviruses. EGEN-2784, a genetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in a multi-patient Expanded Access study at MGH. eGenesis is headquartered in Cambridge, MA. \n\n\nPOSITION SUMMARY\nThe veterinary services team supports the health, welfare, and regulatory compliance of swine herds housed in the Designated Pathogen Free (DPF) and Source Animal Facility (SAF) at eGenesis. The team ensures standardized veterinary medical care, surgical excellence, herd health management, regulatory compliance, and adherence to GMP requirements.\n \nThe Associate Veterinarian reports to the Director of Veterinary Services and serves primarily a clinical role in the SAF and participates frequently in the broader programs for animal health including adventitious agents surveillance, vaccine and sentinel programs. In this role, you will provide clinical and regulatory support for GMP donor production, surgical support for GMP donor production, and participate in Institutional Animal Care and Use Committee and USDA inspections. The Associate Veterinarian participates in the weekly veterinarian on-call schedule. The Clinical Veterinarian serves as back up to the ART Veterinarian and Director of Veterinary Services when necessary, in roles for which they will be cross trained.\n","description":"About eGenesis
eGenesis is a clinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Company’s proprietary genome engineering platform enables extensive, multiplex gene edits to remove key biological barriers, add protective human transgenes, and inactivate endogenous retroviruses. EGEN-2784, a genetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in a multi-patient Expanded Access study at MGH. eGenesis is headquartered in Cambridge, MA.
POSITION SUMMARY
\nThe veterinary services team supports the health, welfare, and regulatory compliance of swine herds housed in the Designated Pathogen Free (DPF) and Source Animal Facility (SAF) at eGenesis. The team ensures standardized veterinary medical care, surgical excellence, herd health management, regulatory compliance, and adherence to GMP requirements.
\n
\nThe Associate Veterinarian reports to the Director of Veterinary Services and serves primarily a clinical role in the SAF and participates frequently in the broader programs for animal health including adventitious agents surveillance, vaccine and sentinel programs. In this role, you will provide clinical and regulatory support for GMP donor production, surgical support for GMP donor production, and participate in Institutional Animal Care and Use Committee and USDA inspections. The Associate Veterinarian participates in the weekly veterinarian on-call schedule. The Clinical Veterinarian serves as back up to the ART Veterinarian and Director of Veterinary Services when necessary, in roles for which they will be cross trained.
","id":"1d6e99c3-15ca-4eed-bb0b-4078be49661b","lists":[{"text":"PRIMARY RESPONSIBILITIES","content":"\nProvide direct clinical and surgical care\nExecute surveillance programs (SAF & DPF)\nReview pathogen results and contribute to Herd Health Reports\nServe as IACUC member and USDA inspection contact\nSupport vaccine program selection and implementation\nParticipate in sentinel optimization strategy\nProvide backup coverage for Director and ART Veterinarian\nParticipate in weekly on-call rotation\nEngage in program communications and review and support ongoing collaboration with Quality and Operations teams.\nParticipate in monthly in-person veterinary team meetings\nContribute to semi-annual review of SOPs and program documents\nTrain in program surgical procedures to provide redundancy in surgical capability across the team\nMaintain surgical expectations by executing standardized procedures and scheduling, owning maintenance of surgical suite readiness, and participating in ongoing surgical training and CE\nImplement medical therapies and heard health program and execute standardized medication use across barns, maintain compliance with GMP and Quality-approved medication lists, participate in annual review of drug treatment spreadsheets, assist with development of standardized primary/secondary/tertiary treatment protocols, consistently document using SOAP format, and adhere to standardized euthanasia endpoint criteria (in coordination with IACUC)\nManage surveillance programs through execution of health sampling for surveillance program, ante-mortem, post-mortem and ad-hoc and review of pathogen detection results and herd health synthesis reporting\nEngage in selection and ordering of vaccines in alignment with the company’s vaccine program\nActively participate in preparation and execution of organ procurement and be available on-call during enrollment/procurement periods.\nSupport organ procurement program through ultrasound qualification of donor pigs and completion of GMP quality documentation.\nSupport regulatory compliance with IACUC participation, provide USDA inspection readiness and representation, SOP authorship and change control participation, and author Quality-driven documentation and impact assessments.\nSupport imaging needs and perform ultrasound procedures for DS/DP animals, perform surrogate pregnancy detection (DPF), train through CE and supervised practice, complete documentation for donor qualification\n"},{"text":"BASIC QUALIFICATIONS","content":"\nDVM or VMD from AVMA-accredited institution; may substitute completion of ECFVG program for graduates of non-AVMA schools\n1-3 years experience as clinical veterinarian working with large animals, preferably swine\nLicense to practice veterinary medicine in at least one state; must attain Indiana licensure within 6 months of hire\nDEA Registration for maintenance of controlled drugs on site\nUSDA Accreditation Category II\nWorking knowledge of regulatory compliance and GMP guidelines\nMust be willing to accept significant learning challenges inherent in a first-in-class biotechnology startup\nExcellent organizational and time management skills and the ability to prioritize work, with attention to detail and resolve to approach problems as an opportunity\nExcellent verbal and written communication skills\nInterpersonal skills necessary to manage others\n"},{"text":"PREFERRED QUALIFICATIONS","content":"\nACLAM board certification or residency training in laboratory animal medicine with eligibility to take ACLAM board exam\nBackground in either swine management/research or experience in breeding/neonate management of any species. Significant swine medicine experience desired.\n1-3 years of management experience\n"}],"text":"Associate Veterinarian","country":"US","workplaceType":"onsite","opening":"About eGenesis
eGenesis is a clinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Company’s proprietary genome engineering platform enables extensive, multiplex gene edits to remove key biological barriers, add protective human transgenes, and inactivate endogenous retroviruses. EGEN-2784, a genetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in a multi-patient Expanded Access study at MGH. eGenesis is headquartered in Cambridge, MA.
","openingPlain":"About eGenesis\neGenesis is a clinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Company’s proprietary genome engineering platform enables extensive, multiplex gene edits to remove key biological barriers, add protective human transgenes, and inactivate endogenous retroviruses. EGEN-2784, a genetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in a multi-patient Expanded Access study at MGH. eGenesis is headquartered in Cambridge, MA. \n","descriptionBody":"POSITION SUMMARY
\nThe veterinary services team supports the health, welfare, and regulatory compliance of swine herds housed in the Designated Pathogen Free (DPF) and Source Animal Facility (SAF) at eGenesis. The team ensures standardized veterinary medical care, surgical excellence, herd health management, regulatory compliance, and adherence to GMP requirements.
\n
\nThe Associate Veterinarian reports to the Director of Veterinary Services and serves primarily a clinical role in the SAF and participates frequently in the broader programs for animal health including adventitious agents surveillance, vaccine and sentinel programs. In this role, you will provide clinical and regulatory support for GMP donor production, surgical support for GMP donor production, and participate in Institutional Animal Care and Use Committee and USDA inspections. The Associate Veterinarian participates in the weekly veterinarian on-call schedule. The Clinical Veterinarian serves as back up to the ART Veterinarian and Director of Veterinary Services when necessary, in roles for which they will be cross trained.
","descriptionBodyPlain":"POSITION SUMMARY\nThe veterinary services team supports the health, welfare, and regulatory compliance of swine herds housed in the Designated Pathogen Free (DPF) and Source Animal Facility (SAF) at eGenesis. The team ensures standardized veterinary medical care, surgical excellence, herd health management, regulatory compliance, and adherence to GMP requirements.\n \nThe Associate Veterinarian reports to the Director of Veterinary Services and serves primarily a clinical role in the SAF and participates frequently in the broader programs for animal health including adventitious agents surveillance, vaccine and sentinel programs. In this role, you will provide clinical and regulatory support for GMP donor production, surgical support for GMP donor production, and participate in Institutional Animal Care and Use Committee and USDA inspections. The Associate Veterinarian participates in the weekly veterinarian on-call schedule. The Clinical Veterinarian serves as back up to the ART Veterinarian and Director of Veterinary Services when necessary, in roles for which they will be cross trained.\n","hostedUrl":"https://jobs.lever.co/egenesisbio/1d6e99c3-15ca-4eed-bb0b-4078be49661b","applyUrl":"https://jobs.lever.co/egenesisbio/1d6e99c3-15ca-4eed-bb0b-4078be49661b/apply"},{"additionalPlain":"\n","additional":"
","categories":{"commitment":"Full-Time","location":"Northwest, Indiana","team":"Quality","allLocations":["Northwest, Indiana"]},"createdAt":1770149561966,"descriptionPlain":"About eGenesis\neGenesis is a clinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Company’s proprietary genome engineering platform enables extensive, multiplex gene edits to remove key biological barriers, add protective human transgenes, and inactivate endogenous retroviruses. EGEN-2784, a genetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in a multi-patient Expanded Access study at MGH. eGenesis is headquartered in Cambridge, MA. \n\n\nPOSITION SUMMARY\nThe Manager of Quality Assurance (QA) is accountable for overseeing the GMP production operations to be conducted at Genesis. This will include supporting the manufacturing operations, facilities/utilities/systems/equipment lifecycle, and supporting all the records generated as part of the manufacturing operations to maintain the GMP facility.\n\nThis role will be responsible for ensuring compliance to GMP standards at eGenesis. This position reports to the Senior Manager of Quality and is a highly visible and impactful position that will require cross-functional interaction across the multiple teams in the organization. \n","description":"About eGenesis
eGenesis is a clinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Company’s proprietary genome engineering platform enables extensive, multiplex gene edits to remove key biological barriers, add protective human transgenes, and inactivate endogenous retroviruses. EGEN-2784, a genetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in a multi-patient Expanded Access study at MGH. eGenesis is headquartered in Cambridge, MA.
POSITION SUMMARY
The Manager of Quality Assurance (QA) is accountable for overseeing the GMP production operations to be conducted at Genesis. This will include supporting the manufacturing operations, facilities/utilities/systems/equipment lifecycle, and supporting all the records generated as part of the manufacturing operations to maintain the GMP facility.
This role will be responsible for ensuring compliance to GMP standards at eGenesis. This position reports to the Senior Manager of Quality and is a highly visible and impactful position that will require cross-functional interaction across the multiple teams in the organization.
","id":"65b9b17c-f92c-4150-91fc-823327850986","lists":[{"text":"PRIMARY RESPONSIBILITIES","content":"Developing, implementing, and maintaining processes to support QA oversight for the manufacturing of drug product to be used in clinical studiesSupporting the development of policies, processes, procedures, and controls ensuring that facility operations conform to established cGMP standards and regulatory requirements and guidelinesSupporting the qualification activities associated with the implementation and release of systems, utilities, facility areas (i.e., manufacturing suites), and equipment onboarding/maintenance for the facilitySupporting day-to-day QA activities associated with manufacturing of drug productReleasing manufacturing suites and batch/product changeovers for continuation of manufacturing activitiesParticipating in cross-functional teams to resolve quality-related issues impacting manufacturing activitiesReviewing and approving documentation such as Manufacturing Batch Records (MBRs), product specifications, change controls, deviations and CAPAs associated with the operations at the manufacturing facilityEvaluating and approving proposed process changes and improvements in the manufacturing area, ensuring that appropriate risk assessments are conducted and proposed changes/improvements are consistent with applicable regulatory guidelinesSupporting investigations associated with critical or major manufacturing deviations and providing the necessary guidance to authorize manufacturing operations, as applicableAuthoring, reviewing, and approving internal quality documents (SOPs, investigations, etc.)Participating in supplier qualification audits and supporting internal audits and regulatory inspections, as neededDeveloping, trending, and reporting of relevant Quality Metrics associated with the area of responsibilityMaintaining the QA Operations function in a state of compliance and inspection readiness"},{"text":"BASIC QUALIFICATIONS","content":"B.S./M.S. in Life Sciences or related field with 5+ years of experience, including leadership, in GMP Quality AssuranceExperience with QA and GMP compliance in clinical biologics productsExperience providing QA oversight to manufacturing operations in a pharmaceutical/ biotechnology environmentAbility to assess vendor quality core processes ensuring compliance with relevant guidelines and proceduresExperience with implementation of electronic system(s) to ensure compliance in 21CFR Part 11 and other applicable regulationsAbility to organize and prioritize workload to meet deadlines and company objectives.Ability to work independently and within cross-functional teamsKnowledge of FDA/EMA/ICH regulations and guidelines regarding clinical production and supply of biopharmaceutics"},{"text":"LEADERSHIP QUALIFICATIONS","content":"Organizational, staff mentorship, and time management skills with attention to detailsHandling multiple assignments in a fast-paced environment with changing prioritiesIndependent development and execution of work plans with minimal supervisionStrong analytical problem-solving, and critical thinking skillsExcellent written and verbal communication skills with the ability to communicate effectively"}],"text":"Manager, Quality Assurance Operations","country":"US","workplaceType":"onsite","opening":"About eGenesis
eGenesis is a clinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Company’s proprietary genome engineering platform enables extensive, multiplex gene edits to remove key biological barriers, add protective human transgenes, and inactivate endogenous retroviruses. EGEN-2784, a genetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in a multi-patient Expanded Access study at MGH. eGenesis is headquartered in Cambridge, MA.
","openingPlain":"About eGenesis\neGenesis is a clinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Company’s proprietary genome engineering platform enables extensive, multiplex gene edits to remove key biological barriers, add protective human transgenes, and inactivate endogenous retroviruses. EGEN-2784, a genetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in a multi-patient Expanded Access study at MGH. eGenesis is headquartered in Cambridge, MA. \n","descriptionBody":"POSITION SUMMARY
The Manager of Quality Assurance (QA) is accountable for overseeing the GMP production operations to be conducted at Genesis. This will include supporting the manufacturing operations, facilities/utilities/systems/equipment lifecycle, and supporting all the records generated as part of the manufacturing operations to maintain the GMP facility.
This role will be responsible for ensuring compliance to GMP standards at eGenesis. This position reports to the Senior Manager of Quality and is a highly visible and impactful position that will require cross-functional interaction across the multiple teams in the organization.
","descriptionBodyPlain":"POSITION SUMMARY\nThe Manager of Quality Assurance (QA) is accountable for overseeing the GMP production operations to be conducted at Genesis. This will include supporting the manufacturing operations, facilities/utilities/systems/equipment lifecycle, and supporting all the records generated as part of the manufacturing operations to maintain the GMP facility.\n\nThis role will be responsible for ensuring compliance to GMP standards at eGenesis. This position reports to the Senior Manager of Quality and is a highly visible and impactful position that will require cross-functional interaction across the multiple teams in the organization. \n","hostedUrl":"https://jobs.lever.co/egenesisbio/65b9b17c-f92c-4150-91fc-823327850986","applyUrl":"https://jobs.lever.co/egenesisbio/65b9b17c-f92c-4150-91fc-823327850986/apply"},{"additional":"","additionalPlain":"","categories":{"commitment":"Full-Time","location":"Cambridge, MA","team":"Clinical Development","allLocations":["Cambridge, MA"]},"createdAt":1773432906159,"descriptionPlain":"About eGenesis\neGenesis is a clinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Company’s proprietary genome engineering platform enables extensive, multiplex gene edits to remove key biological barriers, add protective human transgenes, and inactivate endogenous retroviruses. EGEN-2784, a genetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in a multi-patient Expanded Access study at MGH. eGenesis is headquartered in Cambridge, MA. \n\n\neGenesis is seeking a Senior Clinical Research Associate with 4+ years of experience monitoring complex clinical trials in pharmaceutical, biotechnology, and CRO environments. Demonstrated experience in independently managing investigative sites and conducting site qualification, initiation, routine monitoring (on-site and remote), and closeout visits, while ensuring compliance with ICH-GCP, regulatory requirements, and study protocols. Proven ability to oversee site performance, maintain data integrity through source data verification and CRF review, and ensure timely documentation in eTMF, CTMS, and EDC systems. Skilled in supporting site start-up, training investigators and site staff, and providing operational guidance to academic medical centers and sites with limited IND experience. The ideal person for this role is experienced in identifying operational risks, implementing mitigation strategies, and managing high volume clinical data to maintain patient safety and data quality and study compliance. You will work under the guidance of the Lead CRA or Clinical Operations leadership to execute monitoring strategies and ensure consistent oversight of assigned sites. We are looking for a collaborative team member who works closely with investigative sites and cross-functional teams to support enrollment, resolve operational challenges and maintain inspection readiness.\n","description":"About eGenesis
eGenesis is a clinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Company’s proprietary genome engineering platform enables extensive, multiplex gene edits to remove key biological barriers, add protective human transgenes, and inactivate endogenous retroviruses. EGEN-2784, a genetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in a multi-patient Expanded Access study at MGH. eGenesis is headquartered in Cambridge, MA.
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eGenesis is seeking a Senior Clinical Research Associate with 4+ years of experience monitoring complex clinical trials in pharmaceutical, biotechnology, and CRO environments. Demonstrated experience in independently managing investigative sites and conducting site qualification, initiation, routine monitoring (on-site and remote), and closeout visits, while ensuring compliance with ICH-GCP, regulatory requirements, and study protocols. Proven ability to oversee site performance, maintain data integrity through source data verification and CRF review, and ensure timely documentation in eTMF, CTMS, and EDC systems. Skilled in supporting site start-up, training investigators and site staff, and providing operational guidance to academic medical centers and sites with limited IND experience. The ideal person for this role is experienced in identifying operational risks, implementing mitigation strategies, and managing high volume clinical data to maintain patient safety and data quality and study compliance. You will work under the guidance of the Lead CRA or Clinical Operations leadership to execute monitoring strategies and ensure consistent oversight of assigned sites. We are looking for a collaborative team member who works closely with investigative sites and cross-functional teams to support enrollment, resolve operational challenges and maintain inspection readiness.
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Conduct site qualification, initiation, routine monitoring (on-site and remote), and closeout visits in accordance with the Clinical Monitoring Plan and study timelines\nIndependently manage assigned investigative sites, including academic medical centers with limited IND experience, providing operational guidance to ensure protocol compliance, data quality, and effective management of high-volume clinical data\nOversee clinical trial conduct at assigned sites to ensure protocol compliance, patient safety, data integrity, and accurate documentation\nPerform source data verification and review case report forms (CRFs) to ensure completeness, accuracy, and compliance with study requirements\nPrepare/finalize monitoring visit reports and follow-up communications within required timelines\nTrain and support Principal Investigators and site staff on protocol procedures, regulatory requirements and GCP compliance\nSupport site start-up and activation activities, including collection, review, and tracking of regulatory and essential documents\nContribute to investigator selection and site feasibility assessments during study planning\nPartner with investigative sites to support patient recruitment and retention efforts and address enrollment barriers\nMonitor site performance and key study metrics (e.g., recruitment, data entry timelines, query resolution) to assess site performance and identify potential operational or compliance risks\nEvaluate site operational challenges, implement practical solutions to support site performance and study compliance, and escalate significant issues project leadership as appropriate\nProvide operational guidance and education to investigative site personnel, particularly at academic centers with limited IND experience, to support protocol implementation, regulatory compliance, and management of complex study procedures and data requirements\nSupport risk-based monitoring activities by evaluating site performance indicators and identifying emerging operational or compliance risks\nMaintain accurate and timely documentation of monitoring activities and study records within the eTMF, CTMS, and other required tracking systems\nCollaborate with Clinical Operations and cross-functional teams to support effective study execution\nSupport audit and regulatory inspection readiness, including participation in preparation activities and documentation review\n\n"},{"text":"QUALIFICATIONS","content":"\n\n
Bachelor’s degree in life sciences, nursing, or related field required; advanced degree preferred\n
4+ years of clinical monitoring experience in the pharmaceutical, biotechnology, or CRO industry\n
Experience managing academic medical center sites and supporting investigators or site teams with limited experience in industry-sponsored IND trials\n
Experience managing sites with high data volume and ensuring timely source documentation, CRF completion, and query resolution\n
Direct monitoring experience conducting all monitoring visit types including site qualification, site initiation, interim monitoring, and close-out visits\n
High preference for monitoring complex clinical trials involving critically ill or high-acuity patient populations (e.g., gene/cell therapy or transplant)\n
Strong knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial operations\n
Experience independently managing multiple investigative sites across the monitoring lifecycle and working in a cross-functional team environment\n
Strong organizational, communication, and problem-solving skills\n
Familiarity with eTMF, CTMS, and electronic data capture (EDC) systems\n
Team oriented and flexible; ability to respond quickly to shifting demands and opportunities\n
High attention to detail and commitment to quality\n
Ability to travel as required to conduct on-site monitoring visits\n\n
Base pay range for this job is $105,600-$158,400.
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About eGenesis
eGenesis is a clinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Company’s proprietary genome engineering platform enables extensive, multiplex gene edits to remove key biological barriers, add protective human transgenes, and inactivate endogenous retroviruses. EGEN-2784, a genetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in a multi-patient Expanded Access study at MGH. eGenesis is headquartered in Cambridge, MA.
","openingPlain":"About eGenesis\neGenesis is a clinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Company’s proprietary genome engineering platform enables extensive, multiplex gene edits to remove key biological barriers, add protective human transgenes, and inactivate endogenous retroviruses. EGEN-2784, a genetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in a multi-patient Expanded Access study at MGH. eGenesis is headquartered in Cambridge, MA. \n","descriptionBody":"\n
eGenesis is seeking a Senior Clinical Research Associate with 4+ years of experience monitoring complex clinical trials in pharmaceutical, biotechnology, and CRO environments. Demonstrated experience in independently managing investigative sites and conducting site qualification, initiation, routine monitoring (on-site and remote), and closeout visits, while ensuring compliance with ICH-GCP, regulatory requirements, and study protocols. Proven ability to oversee site performance, maintain data integrity through source data verification and CRF review, and ensure timely documentation in eTMF, CTMS, and EDC systems. Skilled in supporting site start-up, training investigators and site staff, and providing operational guidance to academic medical centers and sites with limited IND experience. The ideal person for this role is experienced in identifying operational risks, implementing mitigation strategies, and managing high volume clinical data to maintain patient safety and data quality and study compliance. You will work under the guidance of the Lead CRA or Clinical Operations leadership to execute monitoring strategies and ensure consistent oversight of assigned sites. We are looking for a collaborative team member who works closely with investigative sites and cross-functional teams to support enrollment, resolve operational challenges and maintain inspection readiness.
\n
About eGenesis
eGenesis is a clinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Company’s proprietary genome engineering platform enables extensive, multiplex gene edits to remove key biological barriers, add protective human transgenes, and inactivate endogenous retroviruses. EGEN-2784, a genetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in a multi-patient Expanded Access study at MGH. eGenesis is headquartered in Cambridge, MA.
POSITION SUMMARY
\nThe Neonatal Care Technician will be responsible for animal care, cleaning, and communication between neonatal and veterinary staff. The individual in this role should be reliable, timely, and observant. This member needs to efficiently perform all required procedures overseen by the neonatal supervisor. All team members must abide by all eGenesis policies and procedures that are relevant to this position.
","id":"6cc8de69-7b7f-40f9-8b5e-9016d1537eb1","lists":[{"text":"PRIMARY RESPONSIBILITIES","content":"\nPerform daily care of piglets in the eGenesis Neonatal facility:\n\nTake daily weights and temperatures of each piglet\nClean daily following provided standard operating procedures (SOPs)\nFeed piglets following provided SOPs\nObserve piglets and record clinical observations\nProvide recommended treatments according to veterinary instruction\n\nIncludes giving emergency care and assisting in veterinary procedures such as sedation/anesthesia, venipuncture, and euthanasia\n\n\nRecord all information in the dedicated databases\n\n\nInterpret and report piglet health status:\n\nExpress interest in furthering knowledge pertaining to piglet health\nWork with all team members to fully understand each piglet’s medical history\nCommunicate piglet clinical signs with supervisor and veterinary staff\n\n\nParticipate in department, division, and other meetings as requested\nBe responsible to ensure SOP compliance:\n\nComplete all training on SOPs relative to the position\nMonitor environment for deviations from the SOPs and inform supervisor\nInform team members and supervisor if any deviations from SOPs are observed to ensure all aspects of the position are being completed correctly\n\n\nPromote and adhere to safety in workplace:\n\nPromote safety awareness\nCorrect unsafe acts and conditions and ensure equipment is properly maintained\nReport and investigate all accidents/incidents
Inspect own area and take remedial action to minimize or eliminate hazards\nComplete required training assignments, forms, and other paperwork\n\n\nEnsure compliance with company biosecurity practices to safeguard health of neonatal animals\nPromote and adhere to the eGenesis animal welfare policies:\n\nFollow all applicable regulatory requirements (USDA, FDA, OLAW) regarding animal welfare and ensure humane care according to the Guide for the Care and Use of Laboratory Animals and the Animal Welfare Act\n\n\nThis position requires that staff work occasional overnight and weekend shifts on a rotating basis shared with other staff, with comp time to accommodate for these schedule changes. As essential personnel, limited on-call or availability for emergency response may occasionally be required.\n"},{"text":"BASIC QUALIFICATIONS","content":"\nExposure to animal handling and basic animal health concerns. Knowledge of equipment disinfection and infection control practices\nAn eagerness to learn or further knowledge relating to animal health\nAttention to detail and problem-solving skills\nExcellent communication and teamwork skills\nProficiency in MS Office\nSchedule flexibility\nAALAS certification (preferred)\n1+ years of relevant experience in animal research or veterinary care (preferred)\nKnowledge and expertise of veterinary procedures (preferred)\nKnowledge and expertise in animal research (preferred)\n"},{"text":"PHYSICAL DEMANDS","content":"\n\n
Able to handle piglets ranging from 1 to 50 kilograms.\nAble to stand and perform cleaning\nMust wear personal protective equipment (PPE)\n\n"},{"text":"WORK ENVIRONMENT","content":"\n
This position operates in multiple environments including office environment (working with computers and printers for documentation purposes), laboratory environment (performing sample collections in pigs and communicating with veterinary staff for sample processing), and farm environment (may be required to use hazardous chemicals, cleaning fecal matter, and operating in dusty environments).
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eGenesis is proud to offer competitive compensation including base pay and annual bonus. We take great care in offering our employees excellent benefits including:
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Medical insurance (80% company paid)\n
Dental insurance (80% company paid)\n
Vision insurance (100% company paid)\n
401k with a company match\n
Paid time off and paid sick time\n
Paid holidays\n\n
About eGenesis
eGenesis is a clinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Company’s proprietary genome engineering platform enables extensive, multiplex gene edits to remove key biological barriers, add protective human transgenes, and inactivate endogenous retroviruses. EGEN-2784, a genetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in a multi-patient Expanded Access study at MGH. eGenesis is headquartered in Cambridge, MA.
","openingPlain":"About eGenesis\neGenesis is a clinical-stage biotechnology company developing human-compatible engineered organs to address the severe global organ shortage. The Company’s proprietary genome engineering platform enables extensive, multiplex gene edits to remove key biological barriers, add protective human transgenes, and inactivate endogenous retroviruses. EGEN-2784, a genetically engineered porcine kidney, is the Company’s lead program and is currently being evaluated in a multi-patient Expanded Access study at MGH. eGenesis is headquartered in Cambridge, MA. \n","descriptionBody":"POSITION SUMMARY
\nThe Neonatal Care Technician will be responsible for animal care, cleaning, and communication between neonatal and veterinary staff. The individual in this role should be reliable, timely, and observant. This member needs to efficiently perform all required procedures overseen by the neonatal supervisor. All team members must abide by all eGenesis policies and procedures that are relevant to this position.
","descriptionBodyPlain":"POSITION SUMMARY\nThe Neonatal Care Technician will be responsible for animal care, cleaning, and communication between neonatal and veterinary staff. The individual in this role should be reliable, timely, and observant. This member needs to efficiently perform all required procedures overseen by the neonatal supervisor. All team members must abide by all eGenesis policies and procedures that are relevant to this position.\n","hostedUrl":"https://jobs.lever.co/egenesisbio/6cc8de69-7b7f-40f9-8b5e-9016d1537eb1","applyUrl":"https://jobs.lever.co/egenesisbio/6cc8de69-7b7f-40f9-8b5e-9016d1537eb1/apply"}]