Manufacturing Programs Senior Manager: Cleaning Validation

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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, reaching over 10 million patients worldwide.

Come do your best work alongside other innovative, driven professionals in this meaningful role. 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 disposable 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.

Let’s do this. Let’s change the world. In this vital role you will be part of ANC’s Manufacturing Support team, and lead cleaning validation teams for both the existing Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and the new Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant. This requires managing cleaning validation teams supporting manufacturing plants in different lifecycle phases.

It is a highly visible role across the site with the key responsibilities of working cross-functionally to ensure compliance of cleaning validation program to regulatory expectations, driving continual improvement, and maintaining alignment to network lessons learned and best practices. This role will also offer the opportunity to propose, participate, and lead team improvement initiatives to drive improved productivity.

• Cross-functional collaboration to ensure on-time delivery of cleaning validation deliverables.
• Provides team oversight, ensuring outputs meet quality and regulatory expectations.
• Support Manufacturing in troubleshooting, problem-solving and RCAs.
• Support CAPA development to prevent error recurrence.
• Establishes Cleaning Validation Program standard work and best practices, ensuring network alignment and incorporation of lessons learned.
• Accountable for inspection readiness strategy and development of inspection readiness tools, standard work, and staff training.
• Champions Lean Transformation and OE initiatives, facilitates the drive towards continuous improvement in the plant, and tracks progress on a plant level.

What we expect of you We are all different, yet we all use our unique contributions to serve patients. The manufacturing professional we seek has a biologics DS manufacturing background with strong cross-functional project management and communication skills as well as the below qualifications.

• Doctorate degree in chemistry, biology or engineering & 2 years of biotechnology operations experience
• Master’s degree in chemistry, biology or engineering & 6 years of biotechnology operations experience
• Bachelor’s degree and 8 years of biotechnology operations experience
• Associate’s degree & 10 years of biotechnology operations experience
• High school diploma / GED & 12 years of biotechnology operations experience
• In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the…