Manager Manufacturing Programs – Process Owner Team

Amgen; Holly Springs (NC); On-site; USD 140,000 - 210,000; Full time

Job summary

Amgen North Carolina seeks a Manager Manufacturing Programs to lead the Process Owner Team in ensuring safe, compliant drug substance manufacturing operations. You will drive technical stewardship, floor support, and readiness activities across upstream/downstream scopes.

The role requires strong leadership, GMP experience, and ability to partner with multiple functions to deliver process governance and continuous improvement within a state-of-the-art facility.

Qualifications

• Doctorate or Master’s degree with 3–5+ years of biotech/pharma manufacturing leadership experience.
• Proven people management experience and leadership of teams, projects, or programs.

Responsibilities

• Lead a team of Process Owners within Manufacturing Support to ensure safe, compliant operations.
• Provide floor support, troubleshooting, and operational readiness activities.
• Oversee CAPA, risk assessments, and change control activities impacting manufacturing operations.
• Collaborate across Manufacturing, Process Development, Quality, Engineering, Supply Chain, and Digital Manufacturing.

Skills

People leadership

GMP manufacturing

Process ownership

MES & EBR

CAPA & change control

Regulatory inspections

Cross-functional collaboration

Operational readiness

Education

Doctorate or Master's in biotech/pharma

Bachelor's in biotech/pharma (with experience)

Tools

MES

Electronic Batch Records (EBR)

CAPA tooling

Single-use tech & BOM familiarity

Job description

At Amgen, our shared mission—to serve patients—drives all that we do. Be part of Amgen North Carolina's newest and most advanced drug substance manufacturing facility, combining single-use technologies, traditional processing equipment, Industry 4.0 capabilities, and sustainability innovations.

Manager Manufacturing Programs – Process Owner Team

What You Will Do

In this vital role, you will lead a team of Process Owners within the Manufacturing Support organization at Amgen North Carolina (ANC). This position may lead either an Upstream & Services-focused team or a Downstream-focused team and requires strong technical expertise in the applicable manufacturing area combined with demonstrated people leadership capabilities.

The Process Owner Team serves as a critical technical interface between Manufacturing Operations and support organizations, ensuring manufacturing processes are effectively translated into operational execution, manufacturing procedures, and digital manufacturing workflows. The team provides technical process stewardship, manufacturing floor support, operational readiness, CAPA implementation support, manufacturing change management, and procedural governance to enable safe, compliant, and reliable manufacturing operations.

• Lead, coach, develop, and manage a team of Process Owners supporting GMP drug substance manufacturing operations.
• Foster a culture of safety, quality, compliance, accountability, collaboration, and continuous improvement.
• Provide leadership for technical process stewardship, manufacturing support, operational readiness, and process governance activities.
• Ensure Process Owners provide effective floor support, hyper‑care, troubleshooting assistance, and manufacturing execution support.
• Oversee operational readiness activities including water runs, dry runs, equipment readiness verification, and Electronic Batch Record (EBR) testing support.
• Drive accountability for execution and timely closure of Process Owner commitments associated with CAPAs, risk assessments, investigation support activities, change controls, and operational readiness activities.
• Lead manufacturing‑related change control implementation activities impacting manufacturing operations (excluding NPI‑related change controls).
• Ensure manufacturing processes are effectively translated into SOPs, manufacturing workflows, training materials, and associated digital manufacturing processes.
• Partner with Manufacturing, Process Development, Quality, Engineering, Supply Chain, Facilities & Engineering, and Digital Manufacturing to support facility fit assessments, process overviews, process implementation, and continuous improvement initiatives.
• Support BOM readiness activities and alignment of single‑use assemblies, consumables, and process materials with manufacturing requirements.
• Ensure appropriate escalation and communication of manufacturing, quality, compliance, and operational risks.
• Support inspection readiness activities and represent the Process Owner organization during audits and regulatory inspections.

What We Expect Of You

Basic Qualifications

• Doctorate degree OR
• Master's degree and 3 years of biotechnology or pharmaceutical manufacturing experience OR
• Bachelor's degree and 5 years of biotechnology or pharmaceutical manufacturing experience OR
• Associate's degree and 10 years of biotechnology or pharmaceutical manufacturing experience OR
• High school diploma / GED and 12 years of biotechnology or pharmaceutical manufacturing experience
• In addition to meeting at least one of the above requirements, you must have 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

• 7+ years of biotechnology or pharmaceutical manufacturing experience with progressively increasing responsibility.
• Demonstrated people leadership experience managing, coaching, and developing technical teams.
• Strong technical expertise in either Upstream & Services manufacturing operations or Downstream manufacturing operations.
• Experience with GMP manufacturing operations, process stewardship, and manufacturing support.
• Experience supporting operational readiness activities, including water runs, dry runs, equipment testing, and startup support.
• Experience with CAPA implementation, CAPA applicability assessments, effectiveness checks, risk assessments, and root cause analysis support.
• Knowledge of drug substance manufacturing equipment, process flows, and manufacturing operations.
• Experience supporting Manufacturing Execution Systems (MES) and Electronic Batch Records (EBRs) within a GMP manufacturing environment.
• Knowledge of single‑use technologies and Bill of Material (BOM) structures.
• Experience partnering with Process Development on facility fit assessments, process implementation, and knowledge transfer activities.
• Strong communication, organizational, and cross‑functional leadership skills.

Benefits

As we work to develop treatments that take care of others, we also care for our teammates’ professional and personal growth and well‑being through comprehensive benefits, career development opportunities, and a collaborative culture.