Senior Manager – Manufacturing Programs - Process Owner Organization

amgen; Holly Springs (NC); On-site; USD 180,000 - 240,000; 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, manufacturing support, governance, and change control across Upstream, Downstream, and Services Drug Substance Unit Operations.

You will mentor Process Owners, build a swing-shift team, and drive safety, quality, compliance, and operational excellence while partnering with Quality, Engineering, and Supply Chain

Qualifications

• Doctorate or higher in a biotechnology/pharmaceutical field with related industry experience.
• 2+ years of direct people leadership experience managing teams or programs.
• Strong GMP manufacturing operations knowledge across Upstream, Downstream and Services Drug Substance Units.
• Experience with process ownership, manufacturing support, and technical stewardship.
• Experience with digital manufacturing systems, EBRs, MES, and GMP documentation.
• Experience authoring and governing GMP documentation and SOPs within quality systems.

Responsibilities

• Lead the Process Owner organization and provide technical process stewardship and manufacturing support.
• Drive manufacturing change control, CAPAs, and procedures for continuous improvement.
• Coordinate with site scheduling for hyper-care support during campaigns and startup activities.
• Partner with Quality, Engineering, Process Development, Supply Chain, and Digital Manufacturing.
• Oversee readiness activities, dry/water/engineering runs, and regulatory inspection readiness.

Skills

GMP knowledge

People leadership

Cross-functional collaboration

Digital manufacturing systems

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma / GED

Tools

EBR systems

MES

Veeva

Documentum

Job description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon‑neutral company by 2027.

Senior Manager – Manufacturing Programs

Live

What you will do

We are seeking a Senior Manager of Manufacturing Programs to lead the Process Owner organization within Manufacturing Support at ANC. This leadership role is responsible for providing technical process stewardship, manufacturing support, process governance, and manufacturing change control support for Upstream, Downstream, and Services Drug Substance Unit Operations.

• Lead and develop the Process Owner organization responsible for providing technical process stewardship and manufacturing support for Upstream, Downstream, and Services Drug Substance Unit Operations.
• Provide direct management, coaching, mentoring, and career development for Process Owners.
• Develop and implement a swing‑shift Process Owner organization to provide expanded manufacturing support and floor coverage.
• Foster a culture of safety, quality, compliance, accountability, collaboration, operational excellence, and continuous improvement.
• Provide strategic leadership for process ownership, operational readiness, manufacturing change implementation, manufacturing procedures, manufacturing CAPAs, and technical process stewardship.
• Coordinate with site scheduling to ensure Process Owners provide timely hyper‑care support and technical assistance during manufacturing campaigns, startup activities, process changes, first‑time executions, and routine operations.
• Serve as the primary interface between Manufacturing Operations and support organizations including Quality, Engineering, Process Development, C & Q, Supply Chain, and Digital Manufacturing.
• Oversee execution of dry runs, water runs, engineering runs, and operational readiness activities supporting manufacturing.
• Own manufacturing‑related CAPAs and change controls associated with process, procedural, and operational improvements.
• Provide leadership and input for electronic batch record (EBR) and manufacturing execution system (MES) implementation activities impacting manufacturing operations.
• Partner with Technology teams to ensure manufacturing processes are effectively translated into digital workflows and manufacturing execution platforms.
• Partner with Supply Chain organizations to ensure manufacturing processes, material strategies, and Bill of Material (BOM) support efficient manufacturing execution.
• Provide process ownership oversight for BOM creation, maintenance, and updates associated with manufacturing process changes.
• Ensure creation, revision, maintenance, and periodic review of GMP documentation supporting manufacturing operations.
• Drive strategic initiatives to improve process reliability, manufacturing efficiency, operator experience, and operational performance.
• Support inspection readiness activities and represent the Process Owner organization during audits and regulatory inspections as required.

What We Expect of You

Basic Qualifications:

• Doctorate degree and 2 years of biotechnology or pharmaceutical industry experience.
• Master’s degree and 6 years of biotechnology or pharmaceutical industry experience.
• Bachelor’s degree and 8 years of biotechnology or pharmaceutical industry experience.
• Associate’s degree and 10 years of biotechnology or pharmaceutical industry experience.
• High school diploma / GED and 12 years of biotechnology or pharmaceutical industry experience.

In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above.

Preferred Qualifications:

• 8+ years related work experience in biotechnology or pharmaceutical manufacturing with progressively increasing responsibility.
• Prior people leadership experience managing and developing technical teams.
• Strong understanding of GMP manufacturing operations supporting Upstream, Downstream, and Services Drug Substance Unit Operations.
• Experience with process ownership, manufacturing support, and technical process stewardship.
• Experience supporting digital manufacturing systems, electronic batch records (EBRs), manufacturing execution systems (MES), and associated process implementation activities within a GMP manufacturing environment.
• Experience authoring, approving, and governing manufacturing SOPs and GMP documentation within Quality Systems (i.e. Veeva, Documentum, etc.).
• Experience leading manufacturing CAPA/ change controls and implementation activities.
• Experience supporting operational readiness activities, including dry runs, water runs, process implementation, and startup support.
• Experience partnering with Supply Chain organizations to support BOM management, material readiness, and manufacturing execution.
• Excellent organizational, written, verbal communication, and cross‑functional leadership skills.