Manager Manufacturing Programs Process Owner Team

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

Job summary

Amgen North Carolina seeks a Manager Manufacturing Programs Process Owner Team to lead a team of Process Owners in GMP drug substance manufacturing. The role encompasses technical process stewardship, floor support, and regulatory readiness, with collaboration across multiple functions.

The position emphasizes safety, quality, compliance, and continuous improvement, with accountability for CAPA, risk assessments, and change controls.

Qualifications

• PhD or higher in biotechnology/pharmaceutical field, or equivalent.
• Master's degree with 3+ years in biotech/pharma manufacturing.
• Bachelor's degree with 5+ years in biotech/pharma manufacturing.
• Associate's degree with 10+ years in biotech/pharma manufacturing.
• High school/GED with 12+ years in biotech/pharma manufacturing.

Responsibilities

• Lead and develop a team of Process Owners across GMP drug substance manufacturing.
• Foster safety, quality, compliance, accountability, and continuous improvement.
• Provide leadership for technical process stewardship and manufacturing support.
• Ensure effective floor support, troubleshooting, and manufacturing execution assistance.
• Oversee readiness activities like water runs, dry runs, and EBR testing.

Skills

People leadership

Team coaching

Project management

Communication

Education

Doctorate degree

Master's degree (biotech/pharma)

Bachelor's degree (biotech/pharma)

Associate's degree

High school / GED

Tools

MES

EBR (Electronic Batch Records)

CAPA systems

Job description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel likeyou'repart of something bigger,it'sbecause you are. At Amgen, our shared missionto serve patientsdrives 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

Live

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 technicalexpertisein the applicable manufacturing area combined withdemonstratedpeopleleadership 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, troubleshootingassistance, and manufacturing execution support.
• Oversee operational readiness activities including water runs, dry runs, equipment readiness verification, and Electronic Batch Record (EBR) testingsupport.
• Drive accountability for execution andtimelyclosure of Process Owner commitments associated with CAPAs, risk assessments, investigation support activities, change controls, and operational readiness activities.
• Lead manufacturing-related change control implementation activitiesimpactingmanufacturing 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 Manufacturingto 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.
• Ensureappropriate escalationand communication of manufacturing, quality, compliance, and operational risks.
• Support inspectionreadiness activities and represent the Process Owner organization during audits and regulatory inspections.

Basic Qualifications

What We Expect of You

• Doctorate degree OR
• Master's degree and3years of biotechnology or pharmaceutical manufacturing experience OR
• Bachelor's degree and5years 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 leadingteams, projects,prograns, or directing the allocationorresources. 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.
• Demonstratedpeopleleadership experience managing, coaching, and developing technical teams.
• Strong technicalexpertisein 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.