Position Overview
Position Summary: The GMP manager oversees GMP regulated manufacturing operations, ensures compliance, supervises manufacturing staff, manages documentation, coordinates with QA/CMOs, and maintains production readiness. Responsible for performing manufacturing operations to support the production of CAR T Cell therapies in accordance with current Good Manufacturing Practices (cGMP). In this role, the manager will adhere to established SOPs, maintain accurate batch records, and uphold quality and safety standards throughout the production process. The role requires some hands-on aseptic processing, routine cell culture and the operation of GMP equipment to ensure quality and reproducibility of manufacturing runs.
Core Responsibilities
Operations Oversight — Coordinate and direct daily GMP operations, including planning, supervision, budgeting, and vendor/supply management. Compliance Management — Ensure adherence to cGMP, OSHA, ADA,...