Senior Manager, Manufacturing Programs & Process Ownership

BioSpace; Holly Springs (NC); On-site; USD 180,000 - 240,000; Full time

Job summary

Amgen in North Carolina seeks a Senior Manager of Manufacturing Programs to lead the Process Owner organization within Manufacturing Support at ANC, providing technical process stewardship, manufacturing support, governance, and change control across Upstream, Downstream, and Services Drug Substance Unit Operations.

The role partners with Quality, Engineering, Process Development, C&Q, Supply Chain, and Digital Manufacturing to ensure processes are governed, implemented, and continuously

Qualifications

• PhD or equivalent with biotechnology/pharmaceutical industry experience.
• Advanced degrees plus leadership experience in GMP environments.
• Experience leading teams, programs, or resources in manufacturing.
• Ability to manage multiple complex projects across Upstream/Downstream/Services Drug Substance.
• Proven capability in digital manufacturing tools and documentation systems.

Responsibilities

• Lead the Process Owner organization for Upstream, Downstream, and Services Drug Substance operations.
• Provide coaching and career development for Process Owners.
• Develop swing-shift Process Owner organization for extended coverage.
• Lead safety, quality, compliance, and operational excellence initiatives.
• Oversee changes to manufacturing processes, CAPAs, and related governance.
• Collaborate with Quality, Engineering, Process Development, C&Q, Supply Chain, and Digital Manufacturing.

Skills

People leadership

GMP manufacturing

Cross-functional collaboration

Process ownership

Digital manufacturing

Education

Doctorate degree

Masters degree

Bachelors degree

Associates degree

High school diploma / GED

Tools

Electronic batch records (EBR)

Manufacturing Execution Systems (MES)

Veeva

Documentum

Job description

Amgen in North Carolina seeks a Senior Manager of Manufacturing Programs to lead the Process Owner organization within Manufacturing Support at ANC, providing technical process stewardship, manufacturing support, governance, and change control across Upstream, Downstream, and Services Drug Substance Unit Operations.

The role partners with Quality, Engineering, Process Development, C&Q, Supply Chain, and Digital Manufacturing to ensure processes are governed, implemented, and continuously