Cell Production Specialist
Core
Prepare for and execute CAR-T cell therapy drug manufacturing operations while maintaining strict GMP compliance.
Role type
Cell Production Specialist (Cell Therapy Manufacturing)
Builds
CAR-T cell therapy drugs
Domain
Biopharmaceuticals / Cell Therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cell culture techniques, gene transduction, aseptic operations, GMP drug production principles, SOP and batch record management, change control documentation, facility maintenance, equipment cleaning, validation activities, independent troubleshooting
Preferred skills
prior experience in cell therapy manufacturing
Technologies
GMP facility systems, cell culture equipment
Responsibilities
Participate in preparation work for CAR-T cell therapy drug production, engage in manufacturing operations and complete required documentation, draft and revise CAR-T therapy-related documents including SOPs and batch records, participate in change control document preparation and revision, perform GMP facility maintenance, equipment cleaning, and validation activities, comply with Quality Management System requirements
Seniority
Mid-level, hands-on IC