Clinical Manufacturing Associate II, Cell Therapy in Devens, MA
Bristol Myers Squibb · Devens, MA
Clinical OperationsFull-timeCompany career page
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Role summary
Bristol Myers Squibb seeks a Clinical Manufacturing Associate II to support cell therapy manufacturing operations at its Devens facility. The role involves executing clinical patient process unit operations, maintaining cGMP compliance, and contributing to manufacturing startup activities in a cleanroom environment.
What they're looking for
- High school diploma plus 2+ years cGMP bioprocessing or cell therapy manufacturing experience
- Knowledge of cGMP regulations, FDA guidance for biologics, and ALCOA+ data integrity principles
- Ability to perform aseptic processing in ISO 5 biosafety cabinets and handle human-derived materials
- Experience with cell washing, separation, cryopreservation, expansion, and automated equipment
- Comfort working in cleanroom environments, strong magnets, and with human blood components
- Flexibility to work assigned shifts including nights, weekends, and holidays
- Bachelor's degree in relevant science or engineering discipline preferred
What you'll be doing
- Execute clinical patient process unit operations following standard operating procedures and batch records
- Complete required documentation for process transfer, validation, and batch record protocols
- Maintain cleanroom environmental conditions and perform aseptic processing with proper disinfection
- Operate manufacturing equipment and manage material and personnel flow across multiple shifts
- Collaborate with support groups to solve technical and operational problems and identify innovative solutions
Privacy & handoff
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