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.

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.

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.

Quality Control Microbiology Specialist