Specialist I&II, Manufacturing
Core
Execute core cell therapy manufacturing operations including cell selection, 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
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 selection, 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 cleaning, 5S, and SHE activities to ensure GMP compliance; Participate in equipment calibration and validation; Support new project process transfer and platform setup; Participate in risk assessment, change control, and deviation management; Conduct internal production floor inspections; Support internal and external audits; Complete personal training plans and train others on processes and GMP requirements.
Seniority
Mid-level, hands-on IC