Specialist Manufacturing New Product Introduction (NPI)

Role Summary

Specialist Manufacturing New Product Introduction (NPI) coordinates with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, and Quality to introduce new Drug Substance products and/or advanced technologies into the Amgen North Carolina Biologics Drug Substance Manufacturing facility. It is a highly visible role across the site, with the core responsibility of hosting cross-functional meetings to drive timelines to support the tech transfer of the program, and opportunities to propose, participate in, and lead team improvement initiatives to drive improved productivity and scheduling accuracy.

Responsibilities

• New Product Introduction 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, ensuring that production documents are accurate and up to date.
• 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.
• Champions Lean Transformation and OE initiatives, facilitates the drive towards continuous improvement in the plant and tracks progress on a plant level.

Qualifications

• Required: High school diploma / GED & 10 years of biotechnology operations experience
• Required: Associate’s degree & 8 years of biotechnology operations experience
• Required: Bachelor’s degree and 4 years of biotechnology operations experience
• Required: Master’s degree in chemistry, biology, or engineering & 2 years of biotechnology operations experience
• Required: Doctorate degree
• Preferred: Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry
• Preferred: Excellent cross-functional project management, meeting facilitation, and technical writing skills
• Preferred: Experience in GMP manufacturing operations
• Preferred: Strong technical knowledge of drug substance processing (chromatography, filtration, buffer compounding) and a broad understanding of related disciplinary areas in bioprocessing (cell culture, harvest)
• Preferred: Ability to organize, analyze and interpret technical data through trend analysis, forecasting, modeling, etc.
• Preferred: Ability to effectively communicate complex technical information with internal and external colleagues at varying organizational levels in both presentation and technical writing forms
• Preferred: Ability to coach, mentor and/or cross train colleagues within core technical areas
• Preferred: Background in lean manufacturing methodologies and operational excellence