Operations Manager, HPC
Core
Lead the hematopoietic progenitor cell (HPC) production team, managing the value stream from donor intake to cryopreservation in a cleanroom environment.
Role type
Senior hands-on IC Operations Manager (cell therapy manufacturing)
Builds
Bone marrow and cell therapy products from organ donor vertebral bodies
Domain
Biotechnology / Cell Therapy / Aseptic Manufacturing
Required skills
Aseptic technique, cleanroom operations, cGTP/cGMP compliance, deviation management, root cause analysis, CAPA leadership, team supervision, batch record review, process validation, FDA inspection support
Preferred skills
Advanced degree in scientific discipline, statistical process control, continuous improvement methodologies, lean management, technology transfer experience
Technologies
None explicitly listed
Responsibilities
Own daily HPC production output from donor intake through cryopreservation; Manage HPC Production Supervisors across shifts; Serve as operator, verifier, or trainer during clinical production; Develop and report production metrics and drive corrective actions; Perform technical review of production batch records; Write and oversee event reports, investigations, and CAPAs; Lead operational changes through project management; Serve as hiring manager for HPC production roles; Lead the Core Team for cross-functional alignment; Maintain process control, capability, and compliance; Establish floor presence schedule and development plans for staff; Partner with Tissue Production, MSAT, Engineering, Quality, and Supply Chain
Seniority
Senior, hands-on IC
