Biotech Process Owner - Upstream/Downstream

Amgen; Holly Springs (NC); On-site; USD 120,000 - 160,000; Full time

Job summary

Amgen North Carolina in Holly Springs seeks a Specialist Manufacturing – Process Owner for Upstream, Downstream, or Services. You will act as technical process steward and key interface between Operations and support groups, driving ownership, troubleshooting, and continuous improvement.

You will partner with Operations, Process Development, Supply Chain, and Engineering to optimize execution, support change controls, CAPA, and MES/EBR activities, ensuring high-quality drug substance production.

Qualifications

• Doctorate or equivalent biotechnology operations experience.
• Master's in Engineering, Biology, Chemistry, Biochemistry, or related field with biotechnology operations 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 the technical process owner for assigned manufacturing processes, equipment, and unit operations.
• Provide manufacturing floor support, troubleshooting assistance, and hypercare during routine manufacturing operations, process changes, startup activities, and first-time executions.
• Support operational readiness activities including water runs, dry runs, equipment readiness verification, and Electronic Batch Record (EBR) testing support.
• Partner with Manufacturing Operations to support reliable, compliant, and efficient manufacturing execution.
• Monitor process performance and identify opportunities for process optimization, operational improvement, and risk reduction.
• Support manufacturing-related change controls associated with process, equipment, procedural, and operational improvements.
• Author, revise, review, and maintain manufacturing SOPs, forms, and other GMP documentation.
• Ensure manufacturing processes are effectively translated into SOPs, manufacturing workflows, training materials, and associated digital manufacturing processes.
• Provide technical input to manufacturing risk assessments and support identification and mitigation of process, equipment, procedural, and operational risks.
• Participate in root cause analysis (RCA) activities and provide technical process expertise to support manufacturing investigations, major deviations, and quality events.
• Support CAPA applicability assessments, CAPA implementation activities, and CAPA effectiveness checks.
• Partner with Process Development to support process overviews, knowledge transfer activities, and facility fit assessments.
• Partner with Supply Chain, Manufacturing, and Engineering to support material readiness and BOM alignment, including single‑use assemblies and consumables.
• Support MES and EBR activities by providing process expertise and manufacturing representation.
• Participate in inspection readiness activities and support audits as required.
• Appropriately escalation process, operational, quality, and compliance concerns.

Skills

biotechnology operations

technical writing

problem solving

communication

organizational skills

Education

Doctorate degree

Master's degree in Engineering/Biology/Chemistry/Biochemistry

Bachelor's degree

Associate's degree

High school diploma / GED

Tools

MES

Electronic Batch Records (EBR)

SOPs

GMP documentation

Job description

Amgen North Carolina in Holly Springs seeks a Specialist Manufacturing – Process Owner for Upstream, Downstream, or Services. You will act as technical process steward and key interface between Operations and support groups, driving ownership, troubleshooting, and continuous improvement.

You will partner with Operations, Process Development, Supply Chain, and Engineering to optimize execution, support change controls, CAPA, and MES/EBR activities, ensuring high-quality drug substance production.