Senior Manager, Manufacturing Programs & Process Ownership

BioSpace; Holly Springs (NC); On-site; USD 140,000 - 200,000; 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, governance, and manufacturing change control support across Upstream, Downstream, and Services Drug Substance operations.

The Senior Manager will guide Process Owners, ensure operational readiness, and drive continuous improvement while expanding the swing-shift team for enhanced coverage and guidance across

Qualifications

• Doctorate or higher in biotechnology/pharmaceuticals with leadership experience.
• Extensive experience (8+ years) in biopharma manufacturing operations.
• Proven ability to lead Process Owner teams and manage programs in GMP environments.
• Experience with digital manufacturing systems and quality systems integration.

Responsibilities

• Lead and develop the Process Owner organization for Upstream, Downstream, and Services Drug Substance operations.
• Provide coaching, mentorship, and career development for Process Owners.
• Establish swing-shift Process Owner team to expand coverage and support.
• Drive safety, quality, compliance, collaboration, and continuous improvement.
• Oversee manufacturing change controls, CAPAs, and SOP governance.
• Coordinate with Quality, Engineering, Process Development, C&Q, Supply Chain, and Digital Manufacturing.

Skills

Process ownership

Leadership

GMP manufacturing

Cross-functional leadership

Digital manufacturing

Quality systems (EBR/MES)

Manufacturing governance

Operational readiness

Education

Doctorate degree in biotechnology/pharma

Master's degree in biotechnology/pharma

Bachelor's degree

Associate degree

High school diploma

Tools

Veeva

Documentum

EBR systems

MES

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, governance, and manufacturing change control support across Upstream, Downstream, and Services Drug Substance operations.

The Senior Manager will guide Process Owners, ensure operational readiness, and drive continuous improvement while expanding the swing-shift team for enhanced coverage and guidance across