Specialist Manufacturing: NPI, Upstream Process Owner
Amgen
Full-time
Remote friendly (Holly Springs, NC)
United States
Operations
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Role Summary
Specialist Manufacturing: NPI, Upstream Process Owner
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 (i.e. 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