Front Line Manufacturing Manager - Downstream Bulk Drug Substance - Days
Core
Lead a team to support the design, build, startup, and operational readiness of a new downstream bulk drug substance manufacturing facility, transitioning to 24/7 operations.
Role type
Front-line manufacturing manager (downstream biologics)
Builds
New drug substance manufacturing facility (FleX Batch)
Domain
Biotechnology / Pharmaceutical manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP manufacturing, downstream purification operations, facility startup and commissioning, technology transfer, team leadership, regulatory compliance, process troubleshooting
Preferred skills
Biologics 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, and operational readiness milestones; 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