Remote CMC Program Director - Cross-Functional Strategy

ProKidney; Winston-Salem (NC); Hybrid; USD 180,000 - 240,000; Full time

Job summary

ProKidney in the United States is seeking a Director, CMC Project Management to lead planning for CMC activities supporting late-stage and commercial regulatory submissions. You will coordinate with QA, Regulatory, Operations and external SMEs to ensure timely IPP deliverables and cross-functional alignment.

The role requires a deep understanding of cell therapy development, strong program management skills, and the ability to drive risk-based decisions and contingency plans.

Qualifications

• Bachelor's degree in sciences or related field; advanced degree preferred.
• 12+ years in biopharmaceutical industry with 6+ years cell therapy experience.
• CMC project management experience in biotech/pharma focused on biologics/cell & gene therapy.
• Proven ability to lead project managers and collaborate cross-functionally.

Responsibilities

• Translate CMC strategy into detailed project plans with deliverables and deadlines.
• Lead cross-functional teams and manage inter-dependencies across Technical Operations.
• Develop and maintain CMC plans and milestones, track content drafts and timelines.
• Facilitate risk analyses, GAP assessments, and strategy discussions.
• Provide status reports and escalate timeline slips and risks.
• Act as primary CMC point of contact for internal stakeholders.

Skills

Hands-on contributor

CMC depth

Cross-functional collaboration

Multi-tasking

Education

Bachelor's degree in sciences or related field

Advanced degree (MS, PhD) preferred

Job description

ProKidney in the United States is seeking a Director, CMC Project Management to lead planning for CMC activities supporting late-stage and commercial regulatory submissions. You will coordinate with QA, Regulatory, Operations and external SMEs to ensure timely IPP deliverables and cross-functional alignment.

The role requires a deep understanding of cell therapy development, strong program management skills, and the ability to drive risk-based decisions and contingency plans.