About this role
About the Role You will interface between the GMP manufacturing teams at Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and Process Development. As part of ANC’s Manufacturing Support team, you will help ensure new products are introduced into the facility, host cross-functional meetings to drive timelines for tech transfer, and lead team-improvement initiatives to boost productivity and scheduling accuracy. What You'll Do
- New Product Introduction (NPI) lead coordinating with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, Quality, and other teams to introduce new Drug Substance products and/or advanced technologies into the plant using project management tools.
- 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 (NPI) Change Controls and collaborates with stakeholders to drive on-time completion.
- Host cross-functional meetings to drive timelines to support the tech transfer of the program into the facility.
- Propose, participate in, and/or lead team improvement initiatives to drive improved productivity and scheduling accuracy.