Quality Control Microbiology Specialist
MadisonOn-siteFull-time
AI Summary
Leads and provides technical oversight of eGenesis’s environmental monitoring program across manufacturing facilities, performing sampling, testing, reporting, and trending in cGMP compliance.
About this role
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
BASIC QUALIFICATIONS
Skills
Aseptic TechniqueCGMP RegulationsData TrendingEnvironmental MonitoringGMP ManufacturingGrowth PromotionMicrobial IDMicrobiology MethodsPlate EnumerationSOPs
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