Specialist Manufacturing New Product Introduction (NPI): Upstream Readiness

Amgen•Holly Springs, NC

1d•$107,545 - $145,503•Onsite

About The Position

Amgen is building its newest and most advanced drug substance manufacturing plant, the Amgen FleX Batch facility, in Amgen North Carolina (ANC). This facility will combine the latest disposable technologies with traditional stainless-steel equipment for maximum operational flexibility. It will feature best-in-class drug substance manufacturing technologies with Industry 4.0 capabilities and integrate sustainability innovations to reduce carbon and waste, aligning with Amgen's goal of being a carbon-neutral company by 2027. The Specialist Manufacturing New Product Introduction (NPI): Upstream Readiness role is a vital position within the ANC Biologics Drug Substance Manufacturing plant. This role serves as a key communicator and interface between the GMP manufacturing teams and Process Development scientific groups. As part of the ANC Manufacturing Support team, the Specialist is responsible for ensuring the successful introduction of new products into the facility. This is a highly visible role across the site, with the primary responsibility of facilitating cross-functional meetings to drive project timelines for the tech transfer of programs into the facility. The role also offers opportunities to propose, participate in, and lead team improvement initiatives aimed at enhancing productivity and scheduling accuracy.

Requirements

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

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 the 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.
Serve as a 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 Root Cause Analysis (RCAs).
Support CAPA development to prevent error recurrence.
Own New Product Introduction (NPI) Change Controls and collaborate with stakeholders to drive on-time completion.
Respond to regulatory questions and/or audit findings.
Champion Lean Transformation and Operational Excellence (OE) initiatives, facilitate continuous improvement in the plant, and track progress on a plant level.