Manufacturing Programs Leader: Process Ownership & Ops

Amgen Inc. (IR); Holly Springs (NC); On-site; USD 154,000 - 209,000; Full time

Job summary

Amgen Inc. (IR) in the United States is seeking a Senior Manager of Manufacturing Programs to lead the Process Owner organization across Upstream, Downstream, and Services Drug Substance Unit Operations.

You will provide direct management, coaching, and career development for Process Owners, and develop a swing-shift team to expand manufacturing support and floor coverage. The role emphasizes safety, quality, compliance, and continuous improvement, with leadership in process ownership, CAPAs,

Qualifications

• Doctorate degree with 2+ years biotech or pharma industry experience.
• Master’s degree with 6+ years biotech or pharma industry experience.
• Bachelor’s degree with 8+ years biotech or pharma industry experience.
• Associate’s degree with 10+ years biotech or pharma industry experience.
• High school diploma / GED with 12+ years biotech or pharma industry experience.

Responsibilities

• Lead the Process Owner organization for Upstream, Downstream and Services Drug Substance Unit Operations.
• Provide direct management, coaching, and career development for Process Owners.
• Develop and implement swing-shift Process Owner organization for expanded coverage.
• Foster a culture of safety, quality, compliance, accountability, collaboration and improvement.
• Coordinate with site scheduling for timely hyper-care support and process readiness.
• Oversee GMP documentation, CAPAs and change controls related to processes and procedures.

Skills

Leadership

Cross-functional collaboration

Process ownership

CAPA management

Change control

Digital manufacturing

GMP knowledge

Education

Doctorate

Master’s

Bachelor’s

Associate’s

High school diploma / GED

Tools

Veeva

Documentum

MES

EBR system

Job description

Amgen Inc. (IR) in the United States is seeking a Senior Manager of Manufacturing Programs to lead the Process Owner organization across Upstream, Downstream, and Services Drug Substance Unit Operations.

You will provide direct management, coaching, and career development for Process Owners, and develop a swing-shift team to expand manufacturing support and floor coverage. The role emphasizes safety, quality, compliance, and continuous improvement, with leadership in process ownership, CAPAs,