Manufacturing Programs Senior Manager: New Product Introduction (NPI)

Career Category Manufacturing Job Description HOW MIGHT YOU DEFY IMAGINATION? 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. Manufacturing Programs Senior Manager: New Product Introduction (NPI) Live What you will do Let’s do this. Let’s change the world. In this vital role you will communicate and interface between the GMP manufacturing teams in the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and Process Development scientific groups. As part of ANC’s Manufacturing Support team, this position is responsible for ensuring new products are successfully introduced into ANC’s biologics manufacturing facility.  It is a highly visible role across the site with the core responsibility of driving cross-functional deliverables supporting the tech transfers into the facility. This role will also offer the opportunity to propose, participate, and lead team improvement initiatives to drive improved productivity and scheduling accuracy.

New Product Introduction (NPI) subject matter expert coordinating with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, Quality, and other teams to introduce new Drug Substance products and/or advanced technologies into the plant using project management tools. Rapid problem-solving capabilities to help the team resolve technical challenges. Leading a team of NPI manufacturing specialists while building a culture that helps staff thrive.  Technical expert who leads or participates in projects, ensuring that production documents are accurate and up to date. Support Manufacturing in troubleshooting, problem-solving and RCAs. Support CAPA development to prevent error recurrence. Champions Lean Transformation and OE initiatives, facilitates the drive towards continuous improvement in the plant, and tracks progress on a plant level. Win 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 and 2 years of biotechnology operations experience Master’s degree in chemistry, biology or engineering & 6 years of biotechnology operations experience or Bachelor’s degree and 8 years of biotechnology operations experience or Associate’s degree & 10 years of biotechnology operations experience or High school diploma / GED & 12 years of biotechnology operations experience AND 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 allocation or resources.  Your managerial experience may run concurrently with the required technical experience referenced above Preferred Qualifications: Degree in Chemical