Specialist Manufacturing – Process Owner - Upstream / Downstream / Services

Role: Process Owner in Manufacturing Support at Amgen's new flexible drug substance manufacturing facility, overseeing upstream, downstream, or services processes. Objectives: ensure reliable, compliant, and efficient GMP manufacturing through process stewardship, troubleshooting, operational readiness, and continuous improvement. Responsibilities: act as technical process expert, support manufacturing execution, lead process change management, author and review GMP documentation, support risk assessments, root cause analyses, CAPA activities, and collaborate with Process Development and Supply Chain. Requirements: Doctorate with 2+ years or Master's with 4+ years or Bachelor's with 6+ years biotech operations experience; technical knowledge in biopharma manufacturing processes, equipment, and GMP protocols. Preferred: experience in GMP biotech/pharma manufacturing, troubleshooting, process validation, change control, and MES/EBR systems, with familiarity in single-use technology and process risk management. High-Value Details: focus on drug substance manufacturing, supporting biologics or cell/gene modalities, with responsibilities spanning process optimization, GMP compliance, and manufacturing support in a regulated environment. Location: North Carolina; no travel specified.