Clinical Manufacturing Associate II, Cell Therapy in Devens, MA
Core
Perform clinical cell therapy manufacturing operations in a cleanroom environment, including aseptic processing, unit operations, and equipment setup.
Role type
Manufacturing Associate (Cell Therapy)
Builds
Clinical cell therapy products for patient treatment
Domain
Biopharmaceuticals / Cell Therapy
Required skills
cGMP compliance, aseptic processing, cleanroom operations, batch record execution, equipment setup, data integrity (ALCOA+), human blood component handling
Preferred skills
Cell washing/separation/cryopreservation/expansion, ISO 5 biosafety cabinet experience, bioreactor operation, FDA biologics guidance knowledge
Technologies
Bioreactors, automated equipment, biosafety cabinets
Responsibilities
Perform clinical patient process unit operations per SOPs and batch records; Execute daily unit operations schedule across multiple shifts; Maintain manufacturing environmental conditions via area disinfection; Collaborate on technical and operational problem solving; Assist in facility and equipment commissioning for new startups.
Seniority
Mid-level, hands-on IC