Senior Manager Manufacturing – Manufacturing Support Manufacturing Systems

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Senior Manager Manufacturing – Manufacturing Support Manufacturing Systems

What you will do

Let’s do this. Let’s change the world. In this vital role you will provide leadership and oversight for a team responsible for New Product Introduction (NPI), Process Ownership (PO), Single-Use Systems (SUS), and Cleaning Validation within the site’s manufacturing operations. You are accountable for the performance, goals, and management of these functions, ensuring operational readiness, compliance, and successful introduction of new products to the Amgen North Carolina Drug Substance manufacturing facility.

• New Product Introduction (NPI): Lead site activities to introduce new products and process changes; conduct facility fit assessments; own change controls, documentation, project management, and cross-functional alignment to achieve operational readiness.
• Program & Governance Leadership: Lead the NPI core team meetings to drive scope, schedule, risks, and decisions; present at Tech Transfer Steering Committee (TTSC) meetings with high-level summaries and project coordination to enable timely governance decisions.
• Process Owners: Oversee process ownership teams accountable for lifecycle management, continuous improvement, and compliance of core manufacturing processes, including process change controls, CAPAs, and SOPs.
• Single-Use Systems: Provide leadership for the design, implementation, change management, and ongoing support of SUS used in manufacturing operations, including the leak and defect management program.
• Cleaning Validation: Direct validation programs and activities related to equipment cleaning validation (CIP/COP), sterilization (SIP/Autoclaves), and controlled temperature chambers.
• Team Leadership: Build, mentor, and develop a high-performing team with clear goals, accountability, and results across all managed functions.
• Cross-functional Leadership: Act as a key liaison with Manufacturing, Quality, Process Development, Supply Chain, Facilities & Engineering, and Finance to align priorities and execution.
• Compliance & Continuous Improvement: Drive operational excellence, ensure regulatory compliance, and foster a culture of safety, Lean Manufacturing, and continuous improvement.

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:

• High school diploma / GED & 12 years Quality and/or Manufacturing experience OR
• Associate’s degree & 10 years of Quality and/or Manufacturing experience OR
• Bachelor’s degree & 8 years of Quality and/or Manufacturing experience OR
• Master’s degree & 6 years of Quality and/or Manufacturing experience OR
• Doctorate degree & 2 years of Quality and/or Manufacturing experience

Preferred Qualifications:

• Current leadership role in a GMP manufacturing facility.
• Experience in biologics manufacturing operations for licensed commercial products.
• Proven track record in NPI/tech transfer and project governance.
• Depth in process validation lifecycle (process design, PPQ, CPV).
• Expertise in SUS management and cleaning validation programs.
• Excellent communication and executive-level presentation skills.
• Experience operating in matrixed, cross-site, or global networks.
• Demonstrated application of Lean/Operational Excellence in drug substance manufacturing.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now and make a lasting impact with the Amgen team!

careers.amgen.com

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

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.