Manufacturing Programs Leader, Process Owner Team

Amgen; Holly Springs (NC); On-site; USD 140,000 - 210,000; Full time

Job summary

Amgen North Carolina seeks a Manager Manufacturing Programs to lead the Process Owner Team in ensuring safe, compliant drug substance manufacturing operations. You will drive technical stewardship, floor support, and readiness activities across upstream/downstream scopes.

The role requires strong leadership, GMP experience, and ability to partner with multiple functions to deliver process governance and continuous improvement within a state-of-the-art facility.

Qualifications

• Doctorate or Master’s degree with 3–5+ years of biotech/pharma manufacturing leadership experience.
• Proven people management experience and leadership of teams, projects, or programs.

Responsibilities

• Lead a team of Process Owners within Manufacturing Support to ensure safe, compliant operations.
• Provide floor support, troubleshooting, and operational readiness activities.
• Oversee CAPA, risk assessments, and change control activities impacting manufacturing operations.
• Collaborate across Manufacturing, Process Development, Quality, Engineering, Supply Chain, and Digital Manufacturing.

Skills

People leadership

GMP manufacturing

Process ownership

MES & EBR

CAPA & change control

Regulatory inspections

Cross-functional collaboration

Operational readiness

Education

Doctorate or Master's in biotech/pharma

Bachelor's in biotech/pharma (with experience)

Tools

MES

Electronic Batch Records (EBR)

CAPA tooling

Single-use tech & BOM familiarity

Job description

Amgen North Carolina seeks a Manager Manufacturing Programs to lead the Process Owner Team in ensuring safe, compliant drug substance manufacturing operations. You will drive technical stewardship, floor support, and readiness activities across upstream/downstream scopes.

The role requires strong leadership, GMP experience, and ability to partner with multiple functions to deliver process governance and continuous improvement within a state-of-the-art facility.