Manager, Process Operations
Core
Lead upstream and downstream production operations for biologics drug substance manufacturing in a state-of-the-art GMP facility.
Role type
Manager, Process Operations (Biologics Manufacturing)
Builds
Biologics drug substance for clinical trials and commercial launch
Domain
Biopharmaceuticals / Biologics Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, upstream/downstream processing, production planning, deviation management, SOP authoring, equipment qualification, root cause analysis, technical leadership, troubleshooting, batch execution
Preferred skills
Single-use systems, facility fit assessments, tech transfer, Lean manufacturing, JMP, Veeva Quality Docs
Technologies
DeltaV, MES, SAP, JMP, Microsoft Office
Responsibilities
Lead team executing upstream/downstream operations, drive cGMP/EHS compliance, maintain floor presence during GMP ops, support operational readiness for new GMP facility, coach and develop direct reports, troubleshoot process issues, initiate deviations and investigations, author SOPs and batch records, oversee production planning, partner on tech transfer programs
Seniority
Manager, hands-on IC with team leadership