Biotech Manufacturing Process Owner – Upstream/Downstream

BioSpace

Holly Springs (NC)

On-site

USD 120,000 - 180,000

Full time

7 days ago

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Benefits offered by this job

Comprehensive benefits

Career development opportunities

Collaborative culture

Job summary

Amgen North Carolina (ANC) is seeking a Specialist Manufacturing Process Owner to join the Manufacturing Support organization. You will serve as the technical process steward, bridging Operations and support groups to ensure compliant, efficient manufacturing and continuous improvement.

In this role you will own assigned processes, provide floor support, lead readiness activities, contribute to risk assessments, CAPAs and change controls, and help translate process knowledge into GMP

Qualifications

Doctorate or equivalent with biotechnology ops experience
Master's degree with engineering/biology/chemistry/biochemistry, 4+ years
Bachelor's with 6+ years, or equivalent combinations

Responsibilities

Serve as technical process owner for assigned processes, equipment, and unit operations.
Provide floor support, troubleshooting, and hypercare during routine operations and first-time runs.
Lead readiness activities including water runs, dry runs, and equipment verification.
Support CAPA, risk assessments, and change controls with manufacturing impact.
Author, revise, and maintain GMP SOPs and documentation.