The Role
Lead and execute environmental monitoring for GMP manufacturing sites: collect and process air/surface samples, document results, trend data, manage deviations, author and review QC records, and support contamination control and cross-functional cleaning/gowning programs. Travel between Wisconsin and Indiana (~20%).
Summary Generated by Built In
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
eGenesis is seeking an innovative QC Microbiology Specialist to lead and provide the technical and strategic oversight of eGenesis’s environmental monitoring program. In this position you will be responsible for hands-on environmental monitoring sampling, testing, reporting and trending of eGenesis GMP manufacturing facilities in Rensselaer, IN. You will ensure activities are executed in a cGMP compliant manner and have the opportunity to work collaboratively on implementation and maintenance of our contamination control program. The ideal candidate will be independently motivated, a strong communicator and demonstrate proficiency in regulatory compliance. This position will be in the Greater Madison Area in Wisconsin.
PRIMARY RESPONSIBILITIES
- Coordinate the environmental monitoring (EM) program at both eGenesis manufacturing facilities ensuring the collection, transport and processing of air and surface samples.
- Manage the schedule for all routine and non-routine monitoring activities internally and with external contract laboratory.
- Perform environmental monitoring sample collection (nonviable, viable, and surface) as well as providing guidance and training on procedures to additional team members.
- Keep complete and accurate documentation in electronic test methods.
- Review and trend environmental monitoring data.
- Support EM and laboratory deviations. Identify and implement corrective actions to prevent reoccurrence.
- Author, review, and/or approve data, SOPs, COAs, protocols, reports, deviations, and other quality records.
- Work collaboratively with QC contamination control representative and work cross functionally to maintain and enhance cleaning/disinfection program, material/equipment and gowning programs as applicable.
- This position will require some travel (~20% of time) between manufacturing sites in Wisconsin and Indiana, but primary location will be in Wisconsin.
BASIC QUALIFICATIONS
- B.S./M.S. in Life Sciences or related field with 0-3 years of experience, in GMP QC Laboratory.
- Proficient in microbiology methods (plate enumeration, growth promotion, microbial ID, etc.) and aseptic technique needed to perform EM in a GMP environment.
- Strong knowledge of US and EU cGMP regulations/guidance.
- The ability to work and lead in a fast-paced environment, manage priorities, and maintain timelines for multiple projects is essential.
- Effective communication skills, both verbal and written, at all levels and across various functions.
Skills Required
- B.S./M.S. in Life Sciences or related field with 0-3 years in a GMP QC laboratory
- Proficiency in microbiology methods (plate enumeration, growth promotion, microbial ID) and aseptic technique
- Experience performing environmental monitoring sampling, testing, reporting, and trending in GMP environments
- Strong knowledge of US and EU cGMP regulations/guidance
- Ability to manage priorities, lead in a fast-paced environment, and meet timelines for multiple projects
- Effective verbal and written communication skills across functions and levels
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The Company
What We Do
eGenesis is revolutionizing the field of transplantation with an unparalleled, multiplexed gene editing platform for the development of human-compatible organs, tissues and cells. Harnessing the latest gene-editing techniques, eGenesis has the capability to solve the global organ crisis by providing an alternative to allotransplantation. eGenesis is uniquely positioned to reinvigorate the field of xenotransplantation by addressing both the key virology and immunology hurdles that have impeded its advancement to date and provide commercially-viable products to save and enhance the lives of patients in need.
