Manager Manufacturing Programs – Process Owner Team
Amgen
August 22, 2026
On-site
Holly Springs, NC
Operations
Manager Manufacturing Programs – Process Owner Team
What You Will Do
- Lead, coach, develop, and manage a team of Process Owners supporting GMP drug substance manufacturing operations.
- Foster a culture of safety, quality, compliance, accountability, collaboration, and continuous improvement.
- Provide technical process stewardship, manufacturing support, operational readiness, and process governance.
- Ensure effective floor support, hypercare, troubleshooting, and manufacturing execution support.
- Oversee operational readiness activities (water runs, dry runs, equipment readiness verification, and Electronic Batch Record (EBR) testing support).
- Drive accountability for timely closure of Process Owner commitments for CAPAs, risk assessments, investigation support, change controls, and operational readiness.
- Lead manufacturing-related change control implementation activities impacting manufacturing operations (excluding NPI-related change controls).
- Translate manufacturing processes into SOPs, workflows, training materials, and digital manufacturing processes.
- Partner cross-functionally (Manufacturing, Process Development, Quality, Engineering, Supply Chain, Facilities & Engineering, Digital Manufacturing) on facility fit, process overviews, implementation, and continuous improvement.
- Support BOM readiness; align single-use assemblies/consumables/process materials with manufacturing requirements.
- Escalate and communicate manufacturing/quality/compliance/operational risks; support inspection readiness and audits.
Basic Qualifications
- Doctorate OR Master’s + 3 years OR Bachelor’s + 5 years OR Associate’s + 10 years OR High school/GED + 12 years in biotech/pharma manufacturing; plus people management/leadership experience leading teams/projects or directing resources.
Preferred Qualifications
- 7+ years with increasing responsibility; demonstrated people leadership.
- Strong Upstream & Services or Downstream technical expertise; GMP operations/process stewardship.
- Operational readiness (water runs/dry runs/equipment testing/startup), CAPA (implementation/effectiveness/risk/root cause), drug substance equipment/process flow knowledge.
- MES and EBR experience in GMP; single-use technologies and BOM structures.
- Facility fit/implementation/knowledge transfer with Process Development; strong communication/organization/cross-functional leadership.
Benefits (explicitly mentioned)
- Comprehensive benefits; career development opportunities; collaborative culture.
What You Will Do
- Lead, coach, develop, and manage a team of Process Owners supporting GMP drug substance manufacturing operations.
- Foster a culture of safety, quality, compliance, accountability, collaboration, and continuous improvement.
- Provide technical process stewardship, manufacturing support, operational readiness, and process governance.
- Ensure effective floor support, hypercare, troubleshooting, and manufacturing execution support.
- Oversee operational readiness activities (water runs, dry runs, equipment readiness verification, and Electronic Batch Record (EBR) testing support).
- Drive accountability for timely closure of Process Owner commitments for CAPAs, risk assessments, investigation support, change controls, and operational readiness.
- Lead manufacturing-related change control implementation activities impacting manufacturing operations (excluding NPI-related change controls).
- Translate manufacturing processes into SOPs, workflows, training materials, and digital manufacturing processes.
- Partner cross-functionally (Manufacturing, Process Development, Quality, Engineering, Supply Chain, Facilities & Engineering, Digital Manufacturing) on facility fit, process overviews, implementation, and continuous improvement.
- Support BOM readiness; align single-use assemblies/consumables/process materials with manufacturing requirements.
- Escalate and communicate manufacturing/quality/compliance/operational risks; support inspection readiness and audits.
Basic Qualifications
- Doctorate OR Master’s + 3 years OR Bachelor’s + 5 years OR Associate’s + 10 years OR High school/GED + 12 years in biotech/pharma manufacturing; plus people management/leadership experience leading teams/projects or directing resources.
Preferred Qualifications
- 7+ years with increasing responsibility; demonstrated people leadership.
- Strong Upstream & Services or Downstream technical expertise; GMP operations/process stewardship.
- Operational readiness (water runs/dry runs/equipment testing/startup), CAPA (implementation/effectiveness/risk/root cause), drug substance equipment/process flow knowledge.
- MES and EBR experience in GMP; single-use technologies and BOM structures.
- Facility fit/implementation/knowledge transfer with Process Development; strong communication/organization/cross-functional leadership.
Benefits (explicitly mentioned)
- Comprehensive benefits; career development opportunities; collaborative culture.