Front Line Manufacturing Manager - Bulk Drug Substance Services - Days
Core
Lead frontline manufacturing operations for a new drug substance facility, managing logistics, weighing, dispensing, and material handling during startup and ramp-up.
Role type
Frontline Manufacturing Manager (Drug Substance Services)
Builds
Drug substance manufacturing operations at a new flexible batch facility
Domain
Biotechnology / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, facility startup and commissioning, team leadership, process troubleshooting, cross-functional collaboration, regulatory inspection readiness, shift management
Preferred skills
Biologics manufacturing, technology transfer, MES/EBR/DeltaV/Maximo/Veeva/LIMS proficiency, conflict resolution
Technologies
MES, EBR, DeltaV, Maximo, Veeva, LIMS
Responsibilities
Lead and coach manufacturing team; support design, build, and operational readiness of new facility; ensure safe cGMP-compliant execution; drive performance in safety, quality, schedule, and cost; support technology transfer and process implementation; maintain inspection readiness; work non-standard shifts including 12-hour rotations.
Seniority
Manager, hands-on IC
