Specialist Manufacturing - NPI / Process Owner - Downstream SME

HOW MIGHT YOU DEFY IMAGINATION?

Youve 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 missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds 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

What you will do

Lets do this. Lets 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 ANCs Manufacturing Support team, this position is responsible for ensuring new products are successfully introduced into ANCs biologics manufacturing facility and ownership of downstream unit operations. 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 as well as process ownership for some downstream process unit operations.

• 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 sophisticated technologies into the plant using project management tools (i.e. Smartsheet).
• Downstream biologics drug substance 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.
• Owns New Product Introduction Change Controls and collaborates with partners to drive accurate completion. Responds to regulatory questions and/or audit findings.
• Ensures that manufacturing production documents (e.g. Standard Operating Procedures) are accurate and up to date.

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 Drug Substance Downstream 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
• Associates degree & 8 years of biotechnology operations experience OR
• Bachelors degree and 4 years of biotechnology operations experience OR
• Masters 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 Downstream GMP manufacturing operations
• Strong technical knowledge of drug substance processing (chromatography, filtration, buffer) and a broad understanding of related disciplinary areas in bioprocessing.
• Ability to coordinate, analyze and interpret technical data through trend analysis, forecasting, modeling, etc.
• Ability to optimally communicate sophisticated technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
• Ability to coach, mentor and/or cross train colleagues within core technical areas

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

for a career that defies imagination

Objects in your future are closer than they appear. Join us.