Manager, Manufacturing
Core
Leads and drives the execution of cGMP manufacturing processes for cell therapies, ensuring safety, compliance, and process reliability.
Role type
Manufacturing Manager (Cell Therapy)
Builds
Cell therapy products
Domain
Biopharmaceuticals / Cell Therapy
Required skills
cGMP compliance, aseptic processing, process troubleshooting, change control management, team leadership, deviation investigation, GxP training oversight, operational planning, cost control
Preferred skills
Cell therapy manufacturing experience, aseptic processing in ISO 5 biosafety cabinets, cell expansion using incubators and single-use bioreactors, cell washing, cell separation, cryopreservation
Technologies
Single-use bioreactors, ISO 5 biosafety cabinets, incubators, cryopreservation equipment
Responsibilities
Manage creation and compliance of Source Governing Documents (SOPs, Batch Records), oversee validated manufacturing system operations, plan and assign resources while controlling costs, maintain compliant and inspection-ready operating areas, drive right-first-time initiatives, prepare and present MRB slides, initiate and drive closure of change controls and investigations, evaluate team performance, verify training compliance for GxP tasks, coordinate with Planning and Quality Assurance, provide on-site coaching and troubleshooting, hire and mentor manufacturing associates
Seniority
Manager, hands-on leadership