Manufacturing Programs Lead – Process Owner Team

Amgen SA; Holly Springs (NC); On-site; USD 140,000 - 190,000; Full time

Job summary

Amgen North Carolina is seeking a Manager Manufacturing Programs – Process Owner Team to lead a group of Process Owners in GMP drug substance operations. You will guide technical process stewardship, readiness activities, and change controls, collaborating with Quality, Engineering, and Supply Chain to ensure compliant manufacturing.

You will drive safety, quality, and continuous improvement, overseeing CAPA activities and ensuring effective floor support, EBR testing, and process governance

Qualifications

• Doctorate or master’s with biotech/pharma manufacturing experience.
• Direct people management and leadership experience required.
• Strong leadership and cross-functional collaboration skills.
• GMP drug substance manufacturing knowledge essential.
• Experience with CAPA, risk assessments, investigations.
• Experience with MES/EBR in GMP environments.

Responsibilities

• Lead, coach, develop, and manage a team of Process Owners in ANC.
• Foster safety, quality, compliance, accountability, and improvement.
• Provide leadership for process stewardship and readiness activities.
• Ensure effective floor support, troubleshooting, and execution.
• Oversee readiness activities: water runs, dry runs, EBR testing.
• Drive CAPA, risk assessments, investigations, and change controls.
• Lead change controls affecting operations (excluding NPI).
• Translate processes into SOPs, workflows, and digital processes.
• Partner with CDMO, Quality, Engineering, Supply Chain, and more.
• Support BOM readiness and single-use BOM alignment.

Skills

People leadership

Cross-functional leadership

GMP manufacturing operations

MES experience

EBR familiarity

CAPA implementation

Single-use technologies

BOM knowledge

Process ownership

Education

Doctorate degree

Master’s degree in biotechnology/pharmaceutical manufacturing

Bachelor’s degree in biotechnology/pharmaceutical manufacturing

Associate’s degree in biotechnology/pharmaceutical manufacturing

High school diploma / GED

Tools

MES software

Electronic Batch Records (EBR) systems

Job description

Amgen North Carolina is seeking a Manager Manufacturing Programs – Process Owner Team to lead a group of Process Owners in GMP drug substance operations. You will guide technical process stewardship, readiness activities, and change controls, collaborating with Quality, Engineering, and Supply Chain to ensure compliant manufacturing.

You will drive safety, quality, and continuous improvement, overseeing CAPA activities and ensuring effective floor support, EBR testing, and process governance