Manager Manufacturing Programs – Process Owner Team

Role: Manager of Manufacturing Programs – Process Owner Team at Amgen North Carolina, leading technical teams supporting GMP drug substance manufacturing. Responsibilities include providing process stewardship, manufacturing support, operational readiness, change management, and procedural governance; fostering a safety and compliance culture; overseeing CAPA, risk assessments, and audits; and collaborating across Manufacturing, Process Development, Quality, Engineering, and Digital Manufacturing. Requirements: Bachelor's degree with 5+ years in biotech/pharma manufacturing or equivalent experience, with demonstrated leadership; strong technical expertise in upstream/downstream manufacturing, GMP operations, and manufacturing support activities. Preferred qualifications include 7+ years in biotech/pharma, experience with process stewardship, MES/EBR systems, single-use technologies, and cross-functional collaboration. High-Value: GMP drug substance manufacturing, process stewardship, operational readiness, CAPA, change control, digital manufacturing workflows, and regulatory inspection support. WorkSetup: Onsite in North Carolina with no explicit travel requirements.