Job Details

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. Supportinspectionreadiness activities and represent the Process Owner organization during audits and regulatory inspections. Win What We Expect of You Basic Qualifications 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. Company We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world's leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide. We live the mission. We win together. We thrive on continual challenge. Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission. At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we're transforming the promise of science and biotechnology into therapies that have the power to restore health. Connect with us to explore how you can Win, Live, and Thrive at Amgen.

Company info Website http:

//careers.amgen.com/ Phone 805-447-1000 Location Corporate Headquarters One Amgen Center Drive Thousand Oaks California 91320-1799 United States