Manufacturing Programs Lead, Process Owner Team

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

Job summary

Amgen in North Carolina seeks a Manager Manufacturing Programs Process Owner Team to lead a skilled group responsible for technical process stewardship and manufacturing support. You will ensure readiness, CAPA execution, and continuous improvement across upstream/downstream operations at ANC.

This role requires strong leadership, GMP knowledge, and collaboration with Quality, Engineering, and Process Development to deliver compliant, reliable drug substance manufacturing.

Qualifications

• Experience leading biotech/pharma manufacturing teams.
• GMP operations knowledge and process stewardship.
• Strong leadership and cross-functional collaboration.
• Ability to mentor Process Owners and drive improvements.
• Knowledge of MES/EBR in GMP environments.

Responsibilities

• 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 translated into SOPs, workflows, training materials, and digital manufacturing processes.
• Partner with Manufacturing, Process Development, Quality, Engineering, Supply Chain, Facilities & Engineering, and Digital Manufacturing to support facility fit assessments, process implementation, and continuous improvement initiatives.
• Support BOM readiness activities and alignment of single-use assemblies, consumables, and process materials with manufacturing requirements.
• Ensure 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.

Skills

Leadership

Process ownership

Cross-functional collaboration

Regulatory compliance

CAPA investigation support

Facility readiness

Single-use technologies

Documentation & SOPs

Education

Doctorate degree

Master's degree

Bachelor's degree

Associate's degree

High school diploma / GED

Tools

MES/EBR systems

Job description

Amgen in North Carolina seeks a Manager Manufacturing Programs Process Owner Team to lead a skilled group responsible for technical process stewardship and manufacturing support. You will ensure readiness, CAPA execution, and continuous improvement across upstream/downstream operations at ANC.

This role requires strong leadership, GMP knowledge, and collaboration with Quality, Engineering, and Process Development to deliver compliant, reliable drug substance manufacturing.