NIGHT SHIFT: Specialist, Lead Manufacturing Associate
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
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP regulations knowledge, aseptic processing, cell washing, cell separation, cryopreservation, automated equipment operation, batch record completion, SOP execution, problem-solving in manufacturing, cleanroom maintenance, shift coordination
Preferred skills
Aseptic processing in ISO 5 biosafety cabinets, handling human-derived materials in BSL-2, cell expansion using incubators and single-use bioreactors
Technologies
Automated cell processing 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 on technical problem-solving; support investigations; train others on SOPs and work instructions; coordinate daily unit operations schedules across shifts; maintain cleanroom environmental conditions and perform area disinfection.
Seniority
Senior, hands-on IC