Manufacturing Programs Senior Manager: New Product Introduction (NPI)

Amgen•Holly Springs, NC

9h•Onsite

About The Position

Amgen is seeking a Manufacturing Programs Senior Manager for New Product Introduction (NPI) to join their newest and most advanced drug substance manufacturing plant, the Amgen FleX Batch facility. This facility combines disposable technologies with traditional stainless-steel equipment for maximum flexibility and integrates industry 4.0 capabilities and sustainability innovations. The role involves communicating and interfacing between GMP manufacturing teams and Process Development scientific groups, ensuring successful introduction of new products into the facility. It is a highly visible role responsible for driving cross-functional deliverables for tech transfers and offers opportunities to lead team improvement initiatives for productivity and scheduling accuracy.

Requirements

Doctorate degree and 2 years of biotechnology operations experience
Master’s degree in chemistry, biology or engineering & 6 years of biotechnology operations experience
Bachelor’s degree and 8 years of biotechnology operations experience
Associate’s degree & 10 years of biotechnology operations experience
High school diploma / GED & 12 years of biotechnology operations experience
A minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Managerial experience may run concurrently with the required technical experience.

Nice To Haves

Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry.
Excellent cross-functional project management, meeting facilitation, and technical writing skills.
Experience in GMP manufacturing operations.
Strong technical knowledge of drug substance processing in Cell Culture or Purification (chromatography, filtration, buffer compounding) 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.
Background in lean manufacturing methodologies and operational excellence.

Responsibilities

Act as a New Product Introduction (NPI) subject matter expert, 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.
Utilize rapid problem-solving capabilities to help the team resolve technical challenges.
Lead a team of NPI manufacturing specialists, fostering a culture that helps staff thrive.
Serve as a technical expert who leads or participates in projects, ensuring production documents are accurate and up to date.
Support Manufacturing in troubleshooting, problem-solving, and Root Cause Analysis (RCAs).
Support CAPA development to prevent error recurrence.
Champion Lean Transformation and Operational Excellence (OE) initiatives, facilitate continuous improvement in the plant, and track progress on a plant level.