Specialist I&II, Manufacturing
Core
Execute core cell therapy manufacturing operations including cell sorting, culture, transduction, purification, formulation, and cryopreservation to complete cell product production tasks according to plan.
Role type
Manufacturing Specialist I&II (Cell Therapy)
Builds
Cell therapy products
Domain
Biopharmaceuticals / Cell Therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Cell culture, aseptic technique, GMP compliance, deviation investigation, CAPA, change control, documentation writing, English proficiency
Preferred skills
None stated
Technologies
None stated
Responsibilities
Execute cell sorting, culture, transduction, purification, formulation, and cryopreservation; Prepare solutions, assemble tubing, perform cleaning and sterilization, and operate/maintain equipment; Manage material requisition, production, clearing, and APS; Participate in equipment validation, risk assessment, and process transfer; Support internal and external audits; Conduct training on management processes and GMP compliance.
Seniority
Mid-level, hands-on IC