Specialist Manufacturing: NPI, Process Owner

Role Summary

Specialist Manufacturing: NPI, Process Owner. You will act as the interface between GMP manufacturing teams at the Amgen North Carolina Biologics Drug Substance Manufacturing plant and Process Development, owning downstream unit operations and driving tech transfer through cross-functional collaboration.

Responsibilities

• New Product Introduction (NPI) lead coordinating with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, and Quality to introduce new Drug Substance products and/or advanced technologies into the plant using project management tools.
• 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.

Qualifications

• Required: High school diploma / GED & 10 years of biotechnology operations experience OR
• Required: Associate’s degree & 8 years of biotechnology operations experience OR
• Required: Bachelor’s degree and 4 years of biotechnology operations experience OR
• Required: Master’s degree in chemistry, biology, or engineering & 2 years of biotechnology operations experience OR
• Required: Doctorate degree

Preferred

• 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

Education

• Bachelor’s degree in chemistry, biology, or engineering (or related field) or higher
• Advanced degrees as listed in qualifications (Master’s or Doctorate) in relevant technical disciplines