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Clinical Manufacturing Associate II, Cell Therapy in Devens, MA

Bristol Myers Squibb · Devens, MA

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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 a clinical startup facility in Devens, MA. The role involves executing patient process unit operations, maintaining cGMP compliance, and collaborating on technical problem-solving in a regulated cleanroom environment.

What they're looking for

  • High school diploma with 2+ years cGMP bioprocessing or cell therapy manufacturing experience
  • Knowledge of cGMP regulations, FDA guidance, and ALCOA+ data integrity principles
  • Ability to perform aseptic processing in cleanroom environments and ISO 5 biosafety cabinets
  • Experience with cell washing, separation, cryopreservation, expansion, and automated equipment
  • Comfort working with human blood components and proximity to strong magnets
  • 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 manufacturing documentation including process transfer, validation, and batch record requirements
  • Maintain cleanroom environmental conditions and perform aseptic processing with area disinfection
  • Operate daily unit operations schedule coordinating people, product, and material flow across shifts
  • Collaborate with support groups to solve technical and operational problems and identify innovative solutions

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Date posted1 day ago
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