Job Description

BASIC QUALIFICATIONS:

• High school diploma / GED and 10 years of biotechnology operations experience OR
• Associate’s degree and 8 years of biotechnology operations experience OR
• Bachelor’s degree and 4 years of biotechnology operations experience OR
• Master’s degree and 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

Let’s do this. Let’s change the world. In this vital role you will communicate and interface between the GMP manufacturing teams in the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and Process Development scientific groups. As part of ANC’s Manufacturing Support team, this position is responsible for ensuring new products are successfully introduced into ANC’s biologics manufacturing facility and ownership of upstream unit operations. It is a highly visible role across the site with the core responsibility of hosting 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 upstream 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).
• 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.