Process Owner: Upstream/Downstream Biotech Manufacturing

Amgen Inc. (IR)

Holly Springs (NC)

On-site

USD 108,000 - 146,000

Full time

14 days+

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Job summary

Amgen NC is seeking a Specialist Manufacturing – Process Owner to lead technical stewardship across Upstream, Downstream, or Services. You will own processes, provide floor support, and drive readiness and continuous improvement with manufacturing operations and quality teams.

The role requires advanced degrees and significant biotechnology operations experience, with collaboration across Process Development, Supply Chain, and Engineering to ensure compliant, efficient manufacturing execution.

Qualifications

Doctorate with 2+ years biotechnology operations experience.
Master’s degree in Engineering, Biology, Chemistry, Biochemistry, or related field with 4+ years experience.
Bachelor’s degree with 6+ years biotechnology operations experience.
Associate’s degree with 10+ years biotechnology operations experience.
High school diploma / GED with 12+ years biotechnology operations experience.

Responsibilities

Serve as Process Owner for assigned manufacturing processes, equipment, and unit operations.
Provide floor support, troubleshooting, and hypercare during routine operations and startup.
Support readiness activities including water runs, dry runs, and EBR testing.
Generate and maintain GMP documentation, SOPs, and manufacturing procedures.
Assist with risk assessments, RCA investigations, CAPA applicability and effectiveness.