Specialist Manufacturing - Process Owner - Upstream / Downstream / Services

Amgen seeks a Process Owner for its advanced North Carolina manufacturing facility to serve as technical steward for upstream, downstream, or manufacturing services operations. The role involves process ownership, floor support, operational readiness, change management, and continuous improvement across assigned manufacturing areas. The successful candidate will partner with operations teams to ensure reliable, compliant execution while maintaining GMP documentation and supporting risk mitigation activities.

Responsibilities

• Serve as technical process owner for assigned manufacturing processes, equipment, and unit operations
• Provide floor support, troubleshooting, and assistance during routine operations, process changes, and startup activities
• Support operational readiness activities including water runs, dry runs, and equipment verification testing
• Monitor process performance and identify optimization opportunities and risks for reduction
• Author, revise, and maintain manufacturing SOPs, forms, and GMP documentation

Requirements

• Doctorate in relevant field with 2 years biotech operations experience, or equivalent education/experience combination up to 12 years
• Technical expertise in upstream, downstream, or manufacturing services processes
• Strong knowledge of drug substance manufacturing processes, equipment, and unit operations
• Experience supporting GMP manufacturing operations in biotech or pharmaceutical environment
• Experience authoring and maintaining GMP documentation including SOPs
• Experience with manufacturing change controls and risk assessments
• Familiarity with Manufacturing Execution Systems and Electronic Batch Records in GMP environments