Senior Manufacturing Programs Lead – Process Ownership

Amgen SA; Holly Springs (NC); On-site; USD 180,000 - 240,000; Full time

Job summary

Amgen is seeking a Senior Manager of Manufacturing Programs to lead the Process Owner organization within Manufacturing Support at ANC. This role provides technical process stewardship, manufacturing support, governance, and change control across Upstream, Downstream, and Services Drug Substance Unit Operations.

You will mentor Process Owners, build a swing-shift team, and drive safety, quality, compliance, and operational excellence while partnering with Quality, Engineering, and Supply Chain

Qualifications

• Doctorate or higher in a biotechnology/pharmaceutical field with related industry experience.
• 2+ years of direct people leadership experience managing teams or programs.
• Strong GMP manufacturing operations knowledge across Upstream, Downstream and Services Drug Substance Units.
• Experience with process ownership, manufacturing support, and technical stewardship.
• Experience with digital manufacturing systems, EBRs, MES, and GMP documentation.
• Experience authoring and governing GMP documentation and SOPs within quality systems.

Responsibilities

• Lead the Process Owner organization and provide technical process stewardship and manufacturing support.
• Drive manufacturing change control, CAPAs, and procedures for continuous improvement.
• Coordinate with site scheduling for hyper-care support during campaigns and startup activities.
• Partner with Quality, Engineering, Process Development, Supply Chain, and Digital Manufacturing.
• Oversee readiness activities, dry/water/engineering runs, and regulatory inspection readiness.

Skills

GMP knowledge

People leadership

Cross-functional collaboration

Digital manufacturing systems

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Tools

EBR systems

MES

Veeva

Documentum

Job description

Amgen is seeking a Senior Manager of Manufacturing Programs to lead the Process Owner organization within Manufacturing Support at ANC. This role provides technical process stewardship, manufacturing support, governance, and change control across Upstream, Downstream, and Services Drug Substance Unit Operations.

You will mentor Process Owners, build a swing-shift team, and drive safety, quality, compliance, and operational excellence while partnering with Quality, Engineering, and Supply Chain