Manager Manufacturing Programs Process Owner Team

Amgen SA; Holly Springs (NC); On-site; USD 140,000 - 190,000; Full time

Job summary

Amgen North Carolina is seeking a Manager Manufacturing Programs – Process Owner Team to lead a group of Process Owners in GMP drug substance operations. You will guide technical process stewardship, readiness activities, and change controls, collaborating with Quality, Engineering, and Supply Chain to ensure compliant manufacturing.

You will drive safety, quality, and continuous improvement, overseeing CAPA activities and ensuring effective floor support, EBR testing, and process governance

Qualifications

• Doctorate or master’s with biotech/pharma manufacturing experience.
• Direct people management and leadership experience required.
• Strong leadership and cross-functional collaboration skills.
• GMP drug substance manufacturing knowledge essential.
• Experience with CAPA, risk assessments, investigations.
• Experience with MES/EBR in GMP environments.

Responsibilities

• Lead, coach, develop, and manage a team of Process Owners in ANC.
• Foster safety, quality, compliance, accountability, and improvement.
• Provide leadership for process stewardship and readiness activities.
• Ensure effective floor support, troubleshooting, and execution.
• Oversee readiness activities: water runs, dry runs, EBR testing.
• Drive CAPA, risk assessments, investigations, and change controls.
• Lead change controls affecting operations (excluding NPI).
• Translate processes into SOPs, workflows, and digital processes.
• Partner with CDMO, Quality, Engineering, Supply Chain, and more.
• Support BOM readiness and single-use BOM alignment.

Skills

People leadership

Cross-functional leadership

GMP manufacturing operations

MES experience

EBR familiarity

CAPA implementation

Single-use technologies

BOM knowledge

Process ownership

Education

Doctorate degree

Master’s degree in biotechnology/pharmaceutical manufacturing

Bachelor’s degree in biotechnology/pharmaceutical manufacturing

Associate’s degree in biotechnology/pharmaceutical manufacturing

High school diploma / GED

Tools

MES software

Electronic Batch Records (EBR) systems

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. 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, hypercare, 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.

Thrive

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