Senior Manager Manufacturing Manufacturing Support Manufacturing Systems

Amgen • Holly Springs, NC

100d

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• 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.
• Accountable for the performance, goals, and management of these functions, ensuring operational readiness, compliance, and successful introduction of new products.
• Lead site activities to introduce new products and process changes; conduct facility fit assessments; own change controls, documentation, project management, and cross-functional alignment.
• Lead the NPI core team meetings to drive scope, schedule, risks, and decisions; present at Tech Transfer Steering Committee (TTSC) meetings.
• Oversee process ownership teams accountable for lifecycle management, continuous improvement, and compliance of core manufacturing processes.
• Provide leadership for the design, implementation, change management, and ongoing support of SUS used in manufacturing operations.
• Direct validation programs and activities related to equipment cleaning validation (CIP/COP), sterilization (SIP/Autoclaves), and controlled temperature chambers.
• Build, mentor, and develop a high-performing team with clear goals, accountability, and results.
• Act as a key liaison with Manufacturing, Quality, Process Development, Supply Chain, Facilities & Engineering, and Finance.
• Drive operational excellence, ensure regulatory compliance, and foster a culture of safety, Lean Manufacturing, and continuous improvement.

Benefits

• Competitive and comprehensive Total Rewards Plans aligned with local industry standards.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree