NPI Project Manager — Biopharma Launch & Tech Transfer

KBI Biopharma, Inc.; North Carolina; Presencial; USD 120.000 - 190.000; Jornada completa

Descripción de la vacante

KBI Biopharma, Inc. in Boulder seeks a Principal Project Manager to coordinate New Product Introductions and Reintroductions, ensuring manufacturing starts on schedule.

You will own milestones, TT/process lock, BOM, procurement, batch records, and supply chain readiness, coordinating with site leadership and QA to mitigate risks. Candidates should have engineering or bioscience background and 5+ years in pharma project management with strong cGMP knowledge.

Formación

• Bachelor’s degree in engineering or bioscience with 8+ years in pharma/biotech and 5+ years of management.
• Experience in project management and GxP operations, with knowledge of cGMP.
• Strong writing, communication and cross-functional coordination skills.

Responsabilidades

• Owns NPI/PRI program coordination for timely manufacturing starts.
• Monitors milestones for OTIF delivery and TT readiness.
• Lead process validation, batch records, BOM, and material procurement coordination.
• Manage Change Control records and supply chain readiness.
• Train and align site leadership on schedule impacts and risk.
• Standardize production record content and formats.

Conocimientos

Project management

GxP operations

Quality systems

cGMP decision making

Regulatory knowledge

Risk assessment

Technical writing

Effective communication

Coordination

Leadership

Educación

Bachelor’s degree in engineering or bioscience

Herramientas

MS Project

Descripción del empleo

KBI Biopharma, Inc. in Boulder seeks a Principal Project Manager to coordinate New Product Introductions and Reintroductions, ensuring manufacturing starts on schedule.

You will own milestones, TT/process lock, BOM, procurement, batch records, and supply chain readiness, coordinating with site leadership and QA to mitigate risks. Candidates should have engineering or bioscience background and 5+ years in pharma project management with strong cGMP knowledge.