Specialist Manufacturing: NPI, Process Owner

• Communicate and interface between the GMP manufacturing teams in the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and Process Development scientific groups
• Ensure new products are successfully introduced into ANC’s biologics manufacturing facility and ownership of downstream unit operations
• Host 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 advanced 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 stakeholders to drive on-time 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

• High school diploma / GED & 10 years of biotechnology operations experience
• Associate’s degree & 8 years of biotechnology operations experience
• Bachelor’s degree and 4 years of biotechnology operations experience
• Master’s degree in chemistry, biology, or engineering & 2 years of biotechnology operations experience
• Doctorate degree
• Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry
• Excellent cross-functional project management, meeting facilitation, and technical writing skills
• Experience in Downstream GMP manufacturing operations
• Strong technical knowledge of drug substance processing (harvest, chromatography, filtration, buffer preparation) and a broad understanding of related disciplinary areas in bioprocessing
• Ability to organize, analyze and interpret technical data through trend analysis, forecasting, modeling, etc.
• Ability to effectively communicate complex 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

• Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry
• Excellent cross-functional project management, meeting facilitation, and technical writing skills
• Experience in Downstream GMP manufacturing operations
• Strong technical knowledge of drug substance processing (harvest, chromatography, filtration, buffer preparation) and a broad understanding of related disciplinary areas in bioprocessing
• Ability to organize, analyze and interpret technical data through trend analysis, forecasting, modeling, etc.
• Ability to effectively communicate complex 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

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards