Lead Manufacturing Associate, Cell Therapy in Devens, MA
Core
Lead Manufacturing Associate responsible for patient process unit operations, aseptic processing, and equipment setup in cell therapy manufacturing.
Role type
Senior IC manufacturing associate (cell therapy)
Builds
Cell therapy products for patients
Domain
Biopharmaceuticals / Cell Therapy
Required skills
cGMP regulations knowledge, aseptic processing, cell washing/separation/cryopreservation/expansion, ISO 5 biosafety cabinet operation, batch record completion, SOP adherence, problem-solving in manufacturing
Preferred skills
BSL-2 containment experience, automated equipment operation, validation protocol execution
Technologies
Bioreactors, incubators, automated manufacturing equipment, ISO 5 biosafety cabinets
Responsibilities
Perform patient process unit operations and support operations per SOPs and batch records; maintain cleanroom environmental conditions via area disinfection; set up manufacturing areas and equipment; collaborate with production planning to execute unit operations schedules; support development of manufacturing operating procedures; assist in quality event investigations.
Seniority
Senior, hands-on IC
