Specialist Manufacturing: NPI, Upstream Process Owner

Role Summary

Specialist Manufacturing: NPI, Upstream Process Owner is responsible for ensuring new products are introduced into the Amgen North Carolina Biologics Drug Substance Manufacturing plant and owning upstream unit operations. The role coordinates cross-functional activities with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, and Quality to drive tech transfer and maintain up-to-date production documents.

Responsibilities

• 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 (e.g. Smartsheet).
• Upstream 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.

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 in chemistry, biology, or engineering & 2 years of biotechnology operations experience OR
• Doctorate degree

• Preferred Qualifications:
• Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry
• Excellent cross-functional project management, meeting facilitation, and technical writing skills
• Experience in Upstream GMP manufacturing operations
• Strong technical knowledge of Upstream drug substance processing (media preparation, cell culture, harvest) 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