Front Line Manufacturing Manager - Bulk Drug Substance Services - Days
Amgen · Holly Springs, NC
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Role summary
Amgen seeks a Manufacturing Manager to lead frontline operations at a new bulk drug substance facility in North Carolina. The role involves managing teams responsible for raw materials, solution preparation, and equipment operations while supporting facility startup, commissioning, and eventual 24/7 manufacturing operations. Initial Monday-Friday daytime hours will transition to 12-hour rotating shifts as operations ramp up.
What they're looking for
- Bachelor's degree in Life Sciences or Engineering preferred; minimum Associate's degree with 10+ years manufacturing experience
- Prior managerial experience directly managing people or leading teams and projects
- cGMP manufacturing experience, preferably 5+ years
- Facility startup, commissioning, or operational readiness experience
- Biologics or drug substance manufacturing services background
- Technology transfer and process implementation experience
- Proficiency with MES/EBR, DeltaV, Maximo, Veeva, LIMS systems
What you'll be doing
- Lead and develop manufacturing team; establish performance expectations and foster safety culture
- Support facility startup, commissioning, qualification, staffing, training, and readiness milestones
- Ensure safe, cGMP-compliant manufacturing operations across safety, quality, schedule, and cost
- Partner across Quality, Engineering, Supply Chain, and Site Leadership for successful startup
- Drive continuous improvement initiatives for efficiency, reliability, and scalability
Privacy & handoff
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