BioSpace is hiring: Senior Manager Manufacturing Manufacturing Support Manufact

Senior Manager Manufacturing – Manufacturing Support & Manufacturing Systems

Join Amgen on a mission to serve patients living with serious illnesses. At Amgen, we aspire to be part of something bigger, driving breakthroughs in Oncology, Inflammation, General Medicine, and Rare Disease to impact millions of patients each year. Our culture is collaborative, innovative, and science‑based, with a focus on challenging opportunities that advance careers while transforming lives.

Be part of Amgen's newest and most advanced drug substance manufacturing facility. The FleX Batch facility will combine single-use technologies with traditional stainless steel equipment, enabling maximum flexibility in operations. It will feature best‑in‑class drug substance manufacturing technologies with Industry 4.0 capabilities and sustainability innovations to support Amgen's carbon‑neutral by 2027 plan.

What You Will Do

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 sites 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
• Associates degree + 10 years of Quality and/or Manufacturing experience OR
• Bachelors degree + 8 years of Quality and/or Manufacturing experience OR
• Masters 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 From Us

We support your professional and personal growth and well‑being through competitive benefits and a collaborative culture. In addition to base salary, Amgen offers competitive Total Rewards Plans aligned with local industry standards. Apply now to make a lasting impact with the Amgen team.

Equal Opportunity Employer: 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. Amgen provides reasonable accommodation to participate in the job application or interview process and to perform essential job functions. Please contact us to request accommodation.