Senior Manufacturing Associate, Cell Therapy in Devens, MA
Core
Execute routine manufacturing operations for cell therapy products in a cleanroom environment, ensuring safety, quality, and compliance with cGMP regulations.
Role type
Senior Manufacturing Associate (Cell Therapy)
Builds
Cell therapy products
Domain
Biopharmaceuticals / Cell Therapy
Required skills
cGMP compliance, aseptic processing, cleanroom operations, batch record documentation, SOP execution, equipment setup, problem solving, training others
Preferred skills
Cell washing, automated equipment operation, cell separation, cryopreservation, ISO 5 biosafety cabinet use, single-use bioreactors, cell expansion
Technologies
Automated equipment, incubators, single-use bioreactors, biosafety cabinets
Responsibilities
Execute operations per SOPs and batch records; complete documentation for process transfer and validation; solve simple problems; perform tasks consistent with safety and quality policies; complete training assignments; train others on SOPs; support investigations; identify innovative solutions; assist in setting up manufacturing areas and equipment; write manufacturing operating procedures; work with production planning to execute daily unit operations schedules; work in cleanroom performing aseptic processing and maintaining environmental conditions.
Seniority
Senior, hands-on IC