HOW MIGHT YOU DEFY IMAGINATION?
If you feel likeyou'repart of something bigger,it'sbecause 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
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.
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.
Ensureappropriate escalationand communication of manufacturing, quality, compliance, and operational risks.
