NPI & Manufacturing Start-Up Lead

KBI Biopharma, Inc.

Durham (NC)

On-site

USD 140,000 - 190,000

Full time

4 days ago

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Job summary

KBI Biopharma, Inc. is seeking a Principal Project Manager to coordinate New Product Introductions and Product Reintroductions at its Boulder site.

The role ensures input for on-time, in-full manufacturing starts, owning metrics for TT and manufacturing readiness, and guiding quality systems and regulatory decisions. The ideal candidate brings 8+ years in biopharma with strong project management, cross-functional leadership, and MS Project proficiency, plus familiarity with cGMP and regulatory

Qualifications

Minimum of a Bachelor’s degree in an engineering discipline, or bioscience and 8+ years in the pharmaceutical/biotechnology field equivalent required and 5+ years management experience.
Experience to include minimum of 5 years project management, 5 years GxP operations.
Must have knowledge to guide cGMP decision making in biopharmaceutical manufacturing with regards to quality systems, manufacturing and validation.

Responsibilities

Coordinate New Product Introductions and Product Reintroductions.
Own and monitor TT schedule, milestones, and batch coordination to ensure on-time manufacturing starts.
Lead NPI/PRI change control activities and ensure CC deliverables are monitored.
Oversee batch records, sample plans, and LIMS coordination to support tech transfer.