Manager Manufacturing Programs – Investigations

Role: Manager of Manufacturing Investigations at Amgen's biologics drug substance facility, leading a team to conduct deviation and environmental monitoring investigations supporting operational excellence and regulatory compliance. Responsibilities: develop and mentor investigation specialists, oversee investigation processes, ensure root cause analysis and CAPA quality, serve as environmental monitoring SME, collaborate cross-functionally with Manufacturing, Quality, Engineering, and others, and support inspections and audits. Requirements: Doctorate; or Master's with 3+ years, Bachelor's with 5+ years, or equivalent experience in biologics manufacturing, microbiology, or quality; proven leadership experience managing teams or projects. HighValue: biologics (drug substance manufacturing), environmental monitoring, contamination control, GMP compliance, investigation leadership, regulatory support, Veeva QMS experience preferred. WorkSetup: not specified; likely on-site given manufacturing context.