About this role
Job title: Front Line Manufacturing Manager - Downstream Bulk Drug Substance - Days
About the Role Amgen is seeking a Front Line Manufacturing Manager - Downstream Bulk Drug Substance to provide frontline leadership for the facility expansion and startup of the FleX Batch facility. The role leads downstream purification operations and collaborates across functions to ensure operational readiness, technology transfer, and ramp-up of manufacturing operations within the new facility.
What You'll Do
- Lead a team responsible for downstream purification operations including column packing, column chromatography, TFF, viral filtration, viral inactivation, conjugation, and final fill.
- Partner with cross-functional teams to ensure successful operational readiness, technology transfer, and ramp-up during facility expansion.
- Support design, build, startup, and operational phases; transition from startup focus to ongoing manufacturing leadership as the facility becomes operational.
- Manage startup schedule, initially Monday–Friday 8:00 am–5:00 pm, with potential non-standard hours, then a 12-hour 2-2-3 schedule (5:45 am–6:15 pm) for 24/7 operations.
- Ensure readiness for commissioning and qualification (C&Q) and engineering execution during startup and transition to manufacturing operations.