Front Line Manufacturing Manager - Upstream Bulk Drug Substance - Days
Core
Lead a team responsible for manufacturing cell culture operations including seed train, SUBs, Perfusion, RTF, Stainless Steel BRXs, Depth Filtration, and Centrifugation during facility startup and ramp-up.
Role type
Frontline Manufacturing Manager (Upstream Bulk Drug Substance)
Builds
Upstream bulk drug substance manufacturing operations for biologics
Domain
Biotechnology / Upstream Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP manufacturing execution, facility startup and commissioning, technology transfer, process troubleshooting, team leadership, regulatory compliance, shift management
Preferred skills
Biologics drug substance manufacturing, MES/EBR/DeltaV/Maximo/Veeva/LIMS proficiency, Area Lead experience, conflict resolution
Technologies
MES, EBR, DeltaV, Maximo, Veeva, LIMS
Responsibilities
Lead, develop, and coach a manufacturing team; support design, build, commissioning, and qualification of new facility; ensure safe, cGMP-compliant execution; partner with Quality, Engineering, and Supply Chain; drive efficiency and reliability improvements; work non-standard shifts including 12-hour rotations.
Seniority
Manager, hands-on IC