HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of.
Be part of Amgen's 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 steel-fed 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 Amgen's aspiration to be carbon neutral by 2027.
Director, Manufacturing Execution
Live
What you will do
Let's do this. Let's change the world. In this vital role you will be accountable for leading all drug substance manufacturing execution activities within our site's 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
Master's degree and 8 years of manufacturing experience
OR
Bachelor's 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.
