Senior Clinical Manufacturing Associate, Cell Therapy Manufacturing
Core
Execute clinical cell therapy manufacturing operations in a cleanroom environment, performing aseptic processing and unit operations to support novel programs.
Role type
Senior Clinical Manufacturing Associate (Cell Therapy)
Builds
Clinical cell therapy products for patients
Domain
Biopharmaceuticals / Cell Therapy
Required skills
cGMP compliance, aseptic processing, cell washing, cell separation, cryopreservation, cell expansion, bioreactor operation, automated equipment handling, ISO 5 biosafety cabinet operation, data integrity (ALCOA+), cleanroom gowning, human blood component handling
Preferred skills
BSL-2 containment experience, knowledge of FDA biologics guidance, travel for training at other sites
Technologies
Bioreactors, automated manufacturing equipment, ISO 5 biosafety cabinets
Responsibilities
Perform patient process unit operations per SOPs and batch records; complete documentation for process transfer and validation protocols; solve simple problems and identify innovative solutions; maintain manufacturing environmental conditions via area disinfection; assist in setting up manufacturing areas and equipment commissioning; support production planning and quality event investigations
Seniority
Senior, hands-on IC