Manufacturing Specialist, Cell Therapy
Core
Execute GMP manufacturing operations for TCR T, CAR T, and allogeneic cell therapy investigational products, ensuring production readiness and quality.
Role type
Manufacturing Specialist (Cell Therapy)
Builds
Investigational cell therapy products
Domain
Biologics / Cell Therapy Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, aseptic technique, cleanroom behavior, batch record execution, equipment operation, troubleshooting, documentation accuracy, shift handover, inventory management, deviation support, mentoring
Preferred skills
primary human cell culture, single-use technologies, automated cell processing, process analytical technologies, CMC regulatory knowledge, MES systems
Technologies
automated cell processing equipment, cell expansion systems, filling equipment, MES, electronic batch records
Responsibilities
Execute manufacturing operations per batch records and SOPs; set up and operate automated/manual processing equipment; maintain cleanroom readiness and aseptic technique; author and review production documentation; troubleshoot manufacturing issues; support technology transfer and process development; train and mentor Associate Specialists; perform Final Drug Product visual inspections.
Seniority
Mid-level, hands-on IC
