Specialist Manufacturing: NPI, Process Owner - Facilities Lead

Career Category

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.

Specialist Manufacturing: NPI, Process Owner - Facilities Lead

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 controls and flow of products, materials, and equipment are in compliance. It is a highly visible role across the site with the core responsibility of hosting cross-functional meetings to drive to timelines to support the tech transfer of the program into the facility. This role will also offer the opportunity to own processes across manufacturing like gowning, and cleaning as well as participate, and lead team improvement initiatives to drive improved productivity and scheduling accuracy.

• New Product Introduction (NPI) lead coordinating with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, as well as Quality to introduce new Drug Substance products and/or advanced technologies into the plant using project management tools (i.e. Smartsheet).
• Technical expert who leads or participates in projects, including aiding in commissioning and qualification and training staff on equipment and processes.
• Support Manufacturing in troubleshooting, problem solving and RCAs. Support CAPA development to prevent error recurrence.
• Ensures that production documents are accurate and up to date.
• Owns New Product Introduction Change Controls and collaborates with partners to drive on-time completion. Responds to regulatory questions and/or audit findings.
• Champions Lean Transformation and OE initiatives, facilitates the drive towards continuous improvement in the plant and tracks progress on a plant level.
• Support deviation resolution and closure for facilities-related deviations with subject matter expert and quality teams, including GEMBAs.
• Supports pre-audit corridor walkthroughs with QA and manufacturing to identify potential issues that need mitigation
• Assist with start-up and return to service activities needed for plant shutdown.

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 multi-functional project management and communication skills as well as the below qualifications.

Basic Qualifications:

• High school diploma / GED & 10 years of biotechnology operations experience OR
• Associate’s degree & 8 years of biotechnology operations experience OR
• Bachelor’s degree and 4 years of biotechnology operations experience OR
• Master’s degree 2years of biotechnology operations experience OR
• Doctorate degree

Preferred Qualifications:

• Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry
• Excellent multi-functional project management, meeting facilitation, and technical writing skills
• Experience in GMP manufacturing operations
• Strong technical knowledge of drug substance processing (chromatography, filtration, buffer compounding) and a broad understanding of related disciplinary areas in bioprocessing (gowning, traffic flow, material flow, facility cleaning, etc.)
• Ability to coordinate, analyze and interpret technical data through trend ana