Manufacturing Programs Lead | Process Ownership & Ops

Amgen; Holly Springs (NC); On-site; USD 180,000 - 230,000; Full time

Job summary

Amgen is seeking a Senior Manager – Manufacturing Programs to lead the Process Owner organization within Manufacturing Support. This role provides technical process stewardship, governance, and change control for upstream, downstream, and services drug substance operations.

The position requires extensive leadership experience, strong GMP knowledge, and a track record of improving process reliability and manufacturing performance within a GMP environment.

Qualifications

• PhD with biotech/pharma experience OR Master’s with 6+ years in biotech/pharma.
• Leadership experience managing teams, projects, or programs.
• Strong GMP knowledge across Upstream/Downstream/Services Drug Substance operations.
• Experience with digital manufacturing systems, EBRs and MES in GMP environments.

Responsibilities

• Lead and develop the Process Owner organization for technical process stewardship and manufacturing support.
• Provide coaching, mentoring, and career development for Process Owners.
• Drive readiness for manufacturing campaigns, startups, and process changes.
• Oversee GMP documentation creation, revision, and periodic reviews; own CAPAs and change controls.
• Partner with Quality, Engineering, and Supply Chain to ensure robust manufacturing execution.

Skills

People leadership

GMP manufacturing

Process ownership

Digital manufacturing systems

CAPA/change controls

Cross-functional collaboration

Documentation SOPs

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Tools

Veeva

Documentum

EBR

MES

Job description

Amgen is seeking a Senior Manager – Manufacturing Programs to lead the Process Owner organization within Manufacturing Support. This role provides technical process stewardship, governance, and change control for upstream, downstream, and services drug substance operations.

The position requires extensive leadership experience, strong GMP knowledge, and a track record of improving process reliability and manufacturing performance within a GMP environment.