Director, Manufacturing Execution

Company: Amgen
Location: Holly Springs
Posted on: March 16, 2026

Job Description:

HOW MIGHT YOU DEFY IMAGINATION? If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Be part of Amgens newest and most advanced drug substance manufacturing site in Holly Springs, North Carolina. The site is expanding to include a second drug substance manufacturing facility, building on the initial biomanufacturing plant to create a FleX Batch manufacturing campus. Together, the two facilities will combine the latest single-use technologies with traditional stainless steelfed batch production, enabling maximum operational flexibility, efficiency, and a reduced physical footprint. Across the site, Amgen is integrating best-in-class drug substance manufacturing technologies, embedded industry 4.0 digital capabilities, and sustainability innovations designed to reduce energy consumption, carbon emissions, and waste generation, supporting Amgens aspiration to be carbon neutral by 2027. Director, Manufacturing Execution Live What you will do Lets do this. Lets change the world. In this vital role you will be accountable for leading all drug substance manufacturing execution activities within our sites second FleX Batch manufacturing facility. This role provides end-to-end operational leadership across Upstream Cell Culture, Downstream Purification, and Services (media and buffer preparation), ensuring safe, compliant, reliable, and cost-effective production of biologic drug substance. The leader will build and lead a high-performing organization responsible for 24/7 manufacturing operations, delivering against safety, quality, supply, cost, and people objectives while fostering a culture of execution excellence, accountability, and continuous improvement. Key Responsibilities Manufacturing Execution Leadership Provide strategic and operational leadership for all execution activities across Upstream, Downstream, and Services operations within the FleX Batch facility. Ensure safe, compliant, and reliable manufacturing of drug substance in accordance with cGMPs, regulatory commitments, and Amgen Quality standards. Own performance across key operational metrics including Safety, Quality (RFT, deviations, CAPA effectiveness), Delivery (schedule adherence, campaign execution), Cost, and People. Ensure robust daily management systems are in place to monitor performance, identify gaps, and drive timely escalation and resolution. Partner cross-functionally with Process Development, Manufacturing Support, Quality, Supply Chain, Engineering, Maintenance, and Digital to ensure seamless execution of production campaigns. Operational Excellence & Continuous Improvement Drive a culture of disciplined execution and continuous improvement. Champion right-first-time performance and reduction of deviations, human performance errors, and process variability. Leverage Industry 4.0 digital tools, automation, and data analytics to enhance process robustness and decision-making. Start-Up & Lifecycle Leadership Support facility start-up, technology transfers, validation activities, and lifecycle management of products manufactured within the FleX Batch facility. Ensure operational readiness for new product introductions, capacity expansions, and process improvements. Drive standardization and harmonization of execution practices across manufacturing areas. People & Culture Leadership Build and develop a diverse, engaged, and high-performing leadership team, including Senior Managers and frontline leaders across all execution areas. Establish a culture of safety, accountability, collaboration, and inclusion. Develop organizational capability, succession pipelines, and leadership bench strength. Model Amgen Values and leadership behaviors; create an environment of trust, transparency, and empowerment. Ensure effective labor and resource planning to support current and future manufacturing demands. Stakeholder & Network Engagement Serve as a key member of the site Manufacturing Leadership Team. Collaborate with Global Manufacturing and other Amgen sites to share best practices and align on network standards. Represent Manufacturing during regulatory inspections, internal audits, and leadership reviews. Engage with senior site and global stakeholders to ensure alignment on priorities, risks, and mitigation plans. Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The manufacturing professional we seek is a leader with these qualifications. Basic Qualifications: Doctorate degree and 4 years of manufacturing experience OR Masters degree and 8 years of manufacturing experience OR Bachelors degree and 10 years of manufacturing experience And 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications: Currently in a leadership position in a GMP manufacturing plant Experience in biologics drug substance manufacturing, including cell culture and purification operations Demonstrated leadership of large-scale GMP manufacturing organizations in a 24/7 environment. 6 years managing a team, leading and managing operations Proven ability to drive operational excellence and continuous improvement initiatives Experience leveraging digital manufacturing systems (MES, automation platforms, data analytics tools) Demonstrated ability to influence across functions and levels of the organization Excellent communication and negotiation skills including executive level communication, and the ability to engage frontline staff through executive leadership Experience in a matrixed, cross-site or global network environments Thrive What you can expect of us 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. Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Keywords: Amgen, Greenville , Director, Manufacturing Execution, Manufacturing , Holly Springs, North Carolina