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 to support facility startup and ramp-up.
Role type
Frontline Manufacturing Manager (Upstream Bulk Drug Substance)
Builds
Cell culture manufacturing operations for biologics/drug substances
Domain
Biotechnology / Upstream Manufacturing
Required skills
cGMP compliance, facility startup and commissioning, technology transfer, team leadership, deviation resolution, regulatory inspection readiness, process troubleshooting
Preferred skills
Biologics/drug substance manufacturing experience, MES/EBR/DeltaV/Maximo/Veeva/LIMS proficiency, prior Area Lead/Manager experience
Technologies
MES, EBR, DeltaV, Maximo, Veeva, LIMS
Responsibilities
Lead and coach a manufacturing team; support design, build, and operational readiness of a new facility; ensure safe, cGMP-compliant execution of cell culture operations; partner with cross-functional teams for technology transfer; drive continuous improvement and efficiency.
Seniority
Manager, hands-on IC