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Director, CMC Project Management at ProKidney - ApplyBlast

Director, CMC Project Management

ProKidney

1 month ago

3.9 on Glassdoor

Remote

Full Time

Director

129 applicants

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About this role

The Director, CMC Project Management leads CMC planning activities and cross-functional strategy to support late-stage and commercial regulatory submissions for cell therapy programs. This role involves managing timelines, identifying gaps, and coordinating with internal experts to ensure the on-time completion of activities through BLA filing and approval. The position requires a technical understanding of cell therapy development and close collaboration with Operations, Quality, and Regulatory teams.

Responsibilities

Manage CMC planning activities and cross-functional teams to support regulatory submissions
Develop and maintain detailed CMC plans, milestones, and risk mitigation strategies
Lead data-driven decision-making and provide status reports on project deliverables

Skills

About ProKidney

prokidney.com

Headquarters

Winston-Salem, North Carolina, United States

Company Size

51-200 employees

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ProKidney is a late clinical‑stage biotechnology company developing a first‑in‑class cell therapy candidate to treat advanced chronic kidney disease (CKD). Their lead program aims to preserve kidney function in patients who have limited therapeutic options and to transform the therapeutic landscape for progressive CKD. As a pioneer in CKD therapeutics, ProKidney is advancing clinical development to demonstrate safety and efficacy of regenerative approaches. The company focuses on addressing a major unmet need in kidney disease through novel cell‑based treatments.