Senior Manager – Manufacturing Programs - Process Owner Organization
Amgen
August 18, 2026
On-site
Holly Springs, NC
Operations
Senior Manager – Manufacturing Programs
Responsibilities:
- Lead and develop the Process Owner organization providing technical process stewardship and manufacturing support for Upstream, Downstream, and Services Drug Substance Unit Operations.
- Provide direct management, coaching, mentoring, and career development for Process Owners.
- Develop and implement a swing-shift Process Owner organization for expanded manufacturing support and floor coverage.
- Foster a culture of safety, quality, compliance, accountability, collaboration, operational excellence, and continuous improvement.
- Provide strategic leadership for process ownership, operational readiness, manufacturing change implementation, manufacturing procedures, manufacturing CAPAs, and technical process stewardship.
- Coordinate with site scheduling for hyper-care support during manufacturing campaigns, startup, process changes, first-time executions, and routine operations.
- Serve as primary interface between Manufacturing Operations and support organizations (Quality, Engineering, Process Development, C&Q, Supply Chain, Digital Manufacturing).
- Oversee dry runs, water runs, engineering runs, and operational readiness activities.
- Own manufacturing-related CAPAs and change controls; provide leadership for EBR and MES implementation.
- Partner with Technology and Supply Chain to translate processes into digital workflows and support BOM/material readiness.
- Ensure GMP documentation creation/revision/maintenance and periodic review.
- Support inspection readiness and represent the Process Owner organization during audits and regulatory inspections as required.
Basic Qualifications (choose one):
- Doctorate + 2 years biotech/pharma industry; or Master’s + 6; or Bachelor’s + 8; or Associate’s + 10; or High school/GED + 12.
- Minimum 2 years managing people and/or leadership experience leading teams/projects/programs or directing resource allocation.
Preferred Qualifications:
- 8+ years increasingly responsible biotech/pharma manufacturing experience.
- People leadership of technical teams; strong GMP understanding.
- Experience with process ownership, technical stewardship, EBR/MES, and SOP/GMP governance (e.g., Veeva, Documentum).
- Experience leading manufacturing CAPAs/change controls; operational readiness (dry/water runs, startup).
- Experience partnering with Supply Chain for BOM management/material readiness.
- Excellent organizational, written/verbal, and cross-functional leadership skills.
Responsibilities:
- Lead and develop the Process Owner organization providing technical process stewardship and manufacturing support for Upstream, Downstream, and Services Drug Substance Unit Operations.
- Provide direct management, coaching, mentoring, and career development for Process Owners.
- Develop and implement a swing-shift Process Owner organization for expanded manufacturing support and floor coverage.
- Foster a culture of safety, quality, compliance, accountability, collaboration, operational excellence, and continuous improvement.
- Provide strategic leadership for process ownership, operational readiness, manufacturing change implementation, manufacturing procedures, manufacturing CAPAs, and technical process stewardship.
- Coordinate with site scheduling for hyper-care support during manufacturing campaigns, startup, process changes, first-time executions, and routine operations.
- Serve as primary interface between Manufacturing Operations and support organizations (Quality, Engineering, Process Development, C&Q, Supply Chain, Digital Manufacturing).
- Oversee dry runs, water runs, engineering runs, and operational readiness activities.
- Own manufacturing-related CAPAs and change controls; provide leadership for EBR and MES implementation.
- Partner with Technology and Supply Chain to translate processes into digital workflows and support BOM/material readiness.
- Ensure GMP documentation creation/revision/maintenance and periodic review.
- Support inspection readiness and represent the Process Owner organization during audits and regulatory inspections as required.
Basic Qualifications (choose one):
- Doctorate + 2 years biotech/pharma industry; or Master’s + 6; or Bachelor’s + 8; or Associate’s + 10; or High school/GED + 12.
- Minimum 2 years managing people and/or leadership experience leading teams/projects/programs or directing resource allocation.
Preferred Qualifications:
- 8+ years increasingly responsible biotech/pharma manufacturing experience.
- People leadership of technical teams; strong GMP understanding.
- Experience with process ownership, technical stewardship, EBR/MES, and SOP/GMP governance (e.g., Veeva, Documentum).
- Experience leading manufacturing CAPAs/change controls; operational readiness (dry/water runs, startup).
- Experience partnering with Supply Chain for BOM management/material readiness.
- Excellent organizational, written/verbal, and cross-functional leadership skills.