NIGHT SHIFT: Specialist, Lead Manufacturing Associate, Cell Therapy
Core
Lead Manufacturing Associate executing routine cell therapy manufacturing operations in a cleanroom environment, ensuring safety, quality, and compliance with cGMP regulations.
Role type
Senior IC manufacturing associate (cell therapy)
Builds
Cell therapy products for patients
Domain
Biopharmaceuticals / Cell Therapy
Required skills
cGMP regulations, aseptic processing, cell washing, cell separation, cryopreservation, automated equipment operation, cleanroom environment management, batch record completion, SOP execution, problem-solving, training others
Preferred skills
Aseptic processing in ISO 5 biosafety cabinets, BSL-2 containment handling, cell expansion using incubators and single-use bioreactors
Technologies
Automated equipment, incubators, single-use bioreactors, biosafety cabinets
Responsibilities
Execute operations per SOPs and batch records; Set up manufacturing areas and equipment; Perform facility and equipment commissioning; Collaborate with support groups to solve technical problems; Support investigations; Train others on SOPs and work instructions; Work in cleanroom environment performing aseptic processing and maintaining environmental conditions.
Seniority
Senior, hands-on IC