Senior Manager – Manufacturing Programs - Process Owner Organization

Role: Senior Manager of Manufacturing Programs at Amgen's new drug substance manufacturing facility, overseeing process ownership and support for Upstream, Downstream, and Services operations. Responsibilities: lead and develop the Process Owner team, provide technical process stewardship, manage operational readiness, manufacturing change controls, and procedural governance; establish and lead a swing-shift support team; collaborate closely with Quality, Engineering, Process Development, C&Q, Supply Chain, and Digital Manufacturing; ensure compliance, safety, and continuous improvement; support digital system integration including EBRs and MES; oversee BOM management and GMP documentation; drive initiatives to enhance process reliability and operational efficiency; represent the organization during audits and inspections. Qualifications: Bachelor’s degree with 8+ years industry experience, including leadership; advanced degrees and more experience preferred. High-value specifics: 8+ years in biotech/pharma manufacturing, GMP environment, process ownership, digital manufacturing systems, electronic batch records, and process support for biologics or drug substance production. Cross-functional collaboration and leadership experience required. Work setup includes leading a growing team with planned shift expansion at a state-of-the-art biotech manufacturing site, emphasizing sustainability and Industry 4.0 capabilities.