Front Line Manufacturing Manager - Upstream Bulk Drug Substance - Days

Amgen • Holly Springs, NC

3d • Onsite

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 next generation drug substance manufacturing facility in North Carolina. We are starting up our first facility and breaking ground on our second facility. Both facilities feature the best in-class drug substance technologies and integrate sustainability innovations to reduce carbon and waste, as part of Amgen’s plan to be a carbon-neutral company by 2027. 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. Join us. Front Line Manufacturing Manager - Upstream Bulk Drug Substance - Days What you will do Let’s do this. Let’s change the world . Amgen is seeking a Manager Manufacturing Upstream to provide frontline leadership supporting the facility expansion program and facility startup. This essential role will lead a team responsible for manufacturing cell culture operations including seed train, SUBs, Perfusion, RTF, Stainless Steel BRXs, Depth Filtration and Centrifugation , while partnering across functions to ensure successful operational readiness, technology transfer, and ramp‑up of manufacturing operations within the new facility. The Manager will play a critical role supporting the design, build, startup, and operational phases of the facility expansion. The position will initially focus on facility startup and operational readiness activities, transitioning to manufacturing leadership as the facility becomes operational. During this phase of the startup , you will be expected to work a Monday – Friday schedule from 8am – 5pm. This role may require work outside standard business hours, including non ‑ standard shifts, as needed to support startup, commissioning and qualification (C&Q), and engineering execution . As the business moves from C&Q to manufacturing operations, this essential position will work on a 12-hour 2-2-3 schedule from 5:45 am to 6:15pm supporting our critical 24/7 manufacturing operations . As Amgen relies upon the regular attendance of all staff members to meet legitimate business needs, the Manager must be able to work assigned 12-hour shift, including during inclement weather, some holidays and requested overtime in support of our operations.

Requirements

• Doctorate degree OR Master’s degree and 3 years of Manufacturing or Operations experience OR Bachelor’s degree and 5 years of Manufacturing or Operations experience OR Associate’s degree and 10 years of Manufacturing or Operations experience OR High school diploma / GED and 12 years of Manufacturing or Operations experience
• Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

Nice To Haves

• Bachelor’s degree in Life Sciences or Engineering
• Experience with facility startup, commissioning, or operational readiness
• Biologics / drug substance manufacturing experience ( Upstream )
• cGMP manufacturing experience (5+ years preferred)
• Experience with technology transfer and process implementation
• Prior Area Lead / Specialist / Manager experience
• Strong leadership, performance management, and conflict‑resolution skills
• Solid understanding of regulatory requirements
• Proficiency with MES/EBR, DeltaV , Maximo, Veeva, LIMS, and electronic quality systems

Responsibilities

• Lead, develop, and coach a manufacturing team; set clear performance expectations; foster a strong culture of safety, quality, and accountability.
• Support design, build, commissioning, qualification (C&Q), staffing, training, and readiness milestones for a new manufacturing facility.
• Ensure safe, cGMP‑compliant execution; drive performance across safety, quality, schedule, and cost; resolve deviations and operational issues.
• Support transfer and implementation of manufacturing processes; ensure manufacturability, troubleshooting, and continuous improvement.
• Partner with Quality, Engineering, NPI, Supply Chain, Validation, and Site Leadership to enable successful startup and ramp‑up.
• Maintain inspection readiness and adherence to regulatory and Amgen quality standards.
• Identify and drive efficiency, reliability, and scalability improvements as operations mature.
• Work non‑standard hours as , transitioning to a 12‑hour 2‑2‑ 3 day shift supporting 24/7 operations.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: No Education Listed
• Number of Employees: 5,001-10,000 employees