Process Owner: Upstream/Downstream & Services

Biopharma Careers; Holly Springs (MS); On-site; USD 108,000 - 146,000; Full time

Job summary

Amgen North Carolina is seeking a Specialist Manufacturing – Process Owner to lead technical stewardship for upstream, downstream, and services processes. You will partner with operations and support teams to drive reliable, compliant manufacturing execution and continuous improvement.

Key requirements include advanced biotech manufacturing experience and hands-on process ownership, with strong knowledge of GMP documentation, CAPA, and MES/EBR systems.

Qualifications

• Doctorate degree with 2 years biotech ops experience or equivalent.
• Master's degree in Engineering, Biology, Chemistry, Biochemistry, or related field with 4 years biotech ops experience.
• Bachelor's degree with 6 years biotech ops experience.
• Associate's degree with 10 years biotech ops experience.
• High school diploma / GED with 12 years biotech ops experience.

Responsibilities

• Serve as the technical process owner for assigned manufacturing processes, equipment, and unit operations.
• Provide manufacturing floor support and hypercare during routine operations and first-time executions.
• Support readiness activities including water runs, dry runs, and equipment readiness verification.
• Collaborate with Manufacturing Operations to ensure reliable, compliant manufacturing execution.
• Monitor process performance and identify opportunities for optimization and risk reduction.
• Support change controls and CAPA activities related to process improvements.
• Maintain GMP documentation and ensure SOPs reflect manufacturing workflows.

Skills

Technical leadership

Biotech manufacturing

Process ownership

Troubleshooting

Documentation

Education

Doctorate degree

Master's degree in Engineering or related field

Bachelor's degree

Associate's degree

High school diploma/GED

Tools

MES

EBR

Job description

Amgen North Carolina is seeking a Specialist Manufacturing – Process Owner to lead technical stewardship for upstream, downstream, and services processes. You will partner with operations and support teams to drive reliable, compliant manufacturing execution and continuous improvement.

Key requirements include advanced biotech manufacturing experience and hands-on process ownership, with strong knowledge of GMP documentation, CAPA, and MES/EBR systems.