About this role
About the Role Amgen is seeking a Front Line Manufacturing Manager for Bulk Drug Substance Services at the Holly Springs site to lead frontline manufacturing operations during the facility expansion and startup. The role will manage a team responsible for core operations and partner across functions to drive operational readiness, technology transfer, and ramp-up as the facility becomes fully operational. What You'll Do
- Provide frontline leadership for manufacturing operations including Raw Material and Solution Logistics, Weighing and Dispensing, Buffer/Media Solution Preparation, Parts Washer, Autoclave, and material handling.
- Collaborate across functions to ensure successful operational readiness, technology transfer, and ramp-up of manufacturing operations in the new facility.
- Support design, build, startup, and operational phases of the facility expansion; initially focus on startup and readiness, transitioning to full manufacturing leadership.
- Adapt to schedule changes: during startup, work Monday–Friday 8am–5pm; as operations mature, support a 12-hour 2-2-3 schedule (5:45 am–6:15 pm) for 24/7 manufacturing. What We're Looking For
- Bachelor’s degree in engineering, life sciences, or related field.
- Proven experience leading manufacturing operations in biotech/pharma or drug substance environments.
- Knowledge of commissioning and qualification (C&Q), technology transfer, and ramp-up activities.
- Strong cross-functional collaboration, communication, and leadership skills.
- Ability to work non-standard shifts and adapt to evolving startup/operational demands.
- Familiarity with equipment such as autoclaves, washers, and buffer/media preparation is a plus.
- Facility startup experience is preferred. Nice to Have
- Experience with disposable technologies and flexible manufacturing environments (FleX Batch) and Industry 4.0 capabilities.
- Exposure to sustainability initiatives and carbon-reduction efforts in manufacturing.
- Prior experience in a large-scale drug substance facility during expansion or startup. Compensation & Benefits
- Not specified in posting.