Associate II Manufacturing, Cell Therapy
Core
Execute routine manufacturing operations for novel cell therapy programs in a controlled cleanroom environment, ensuring safety, quality, and GMP compliance.
Role type
Associate II manufacturing operator (cell therapy)
Builds
Commercial manufacturing of personalized cell therapy products for blood cancer patients
Domain
Biopharmaceuticals / Cell Therapy Manufacturing
Required skills
cGMP regulations knowledge, aseptic processing, batch record execution, electronic system transactions, safety event reporting, cleanroom maintenance, SOP adherence, team collaboration
Preferred skills
Cell washing, cell separation, cryopreservation, cell expansion, automated equipment operation, single-use bioreactors, peer-level floor leadership
Technologies
LIMS, ERP, electronic batch records, word processing, spreadsheet applications, web-based systems
Responsibilities
Perform patient process unit operations and execute daily unit operations schedule; Maintain manufacturing environmental conditions via area disinfection; Train others on SOPs and work instructions; Collaborate with support groups to solve technical and operational problems; Complete training assignments to ensure technical proficiency; Escalate issues impacting safety.
Seniority
Associate II, hands-on IC