NPI Coordinator

Job Description

The NPI Coordinator supports NPI activities in a GMP biologics Drug Substance facility by coordinating timelines, materials, documentation, and cross-functional communication across Operations, CMC, Clinical Supply Chain, and Site teams.

Key Responsibilities:

• NPI & Program Coordination: Support NPI tech transfers into GMP DS manufacturing. Lead kickoff, work-cell, and core team meetings. Track timelines, risks, and deliverables.

• Timeline & Material Management: Sequence new programs into the production schedule. Support material forecasting, safety stock, and demand planning. Ensure timely material release and flag risks.

• Documentation & Tools: Maintain SharePoint and program documents. Build slide decks and meeting materials. Use Excel for tracking; support MS Project and NPI tools.

• Operations & Change ControlL Align activities to the Master Production Schedule. Support change controls and cross-functional execution. Assist with basic budget tracking.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:

Skills and Requirements

• Bachelor's degree in Life Sciences or Engineering.

• Experience in a GMP-regulated biotech/pharmaceutical environment.

• Experience in clinical or commercial biologics DS manufacturing.

• Understanding of upstream and downstream biologics processes.

• Experience with project coordination or project management experience within a GMP setting.

• Strong understanding of planning, material handling, manufacturing operations, and GMP compliance.