Remote NPI Manufacturing Programs Lead

BioSpace

Holly Springs (NC)

On-site

USD 150,000 - 210,000

Full time

25 hours ago

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Job summary

Amgen in North Carolina seeks a Manufacturing Programs Senior Manager to lead New Product Introduction (NPI) at the biologics Drug Substance site. You will coordinate with Manufacturing, Process Development, Supply Chain, Planning, Facilities and QA to ensure smooth tech transfers and robust documentation.

This role drives cross-functional delivery, leads a team of NPI manufacturing specialists, champions Lean and Operational Excellence, and interfaces with Process Development and Manufacturing

Qualifications

Doctorate/masters/bachelors/associates/high school with biotechnology operations experience.
Minimum 2 years of people leadership or project leadership experience.

Responsibilities

Coordinate NPI with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, QA.
Rapid problem-solving to resolve technical challenges.
Lead a team of NPI manufacturing specialists and foster staff growth.
Ensure production documents are accurate and up to date.
Support Manufacturing in troubleshooting, RCAs, and CAPA development.
Champion Lean Transformation and OE initiatives; track plant-level progress.

Skills

Cross-functional project management

Communication skills

Lean manufacturing

Operational excellence

Problem solving

Education

Doctorate + biotech ops

Masters + biotech ops

Bachelors + biotech ops

Associates + biotech ops

High school + biotech ops

Tools

GMP manufacturing operations

Job description

This role drives cross-functional delivery, leads a team of NPI manufacturing specialists, champions Lean and Operational Excellence, and interfaces with Process Development and Manufacturing

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