Senior Manager: Manufacturing - Downstream Bulk Drug Substance
Amgen
September 09, 2026
Full-time
On-site
Holly Springs, NC
Operations
Role: Senior Manager of Manufacturing (Downstream) at Amgen's new drug substance facility, leading 24/7 downstream purification operations. Responsibilities: oversee commissioning, qualification, start-up, and GMP manufacturing; develop and lead a high-performing, diverse team; ensure operational readiness, safety, quality, compliance, and continuous improvement; collaborate cross-functionally with Engineering, Quality, Process Development, and Automation teams; lead downstream chromatography column packing activities, troubleshoot issues, and support regulatory inspections; manage shift coverage and operational metrics post-start-up. Requirements: Doctorate with 2+ years, Master's with 6+ years, Bachelor's with 8+ years, or equivalent experience in manufacturing/operations; 2+ years of managerial experience leading teams or projects. Preferred: GMP drug substance manufacturing experience, operational excellence, lean manufacturing, cross-functional expertise in process development, quality, or engineering; strong communication, leadership, and relationship-building skills. HighValue: biologics drug substance, GMP, downstream purification, facility start-up, regulatory compliance, cross-functional leadership, operational excellence. WorkSetup: not specified; likely onsite given facility focus.