Director, CMC Program Management – Cell Therapy Lead

ProKidney Corp.; Winston-Salem (NC); On-site; USD 180,000 - 240,000; Full time

Job summary

ProKidney Corp. is seeking a Director, CMC Project Management to lead CMC planning activities for late-stage and regulatory submissions, coordinating cross-functional teams to deliver a robust Integrated Project Plan.

The role requires deep CMC expertise in cell therapy, strong timeline management, and collaboration with Operations, Quality, Regulatory and Program Management to ensure timely BLA filing and inspection readiness.

Qualifications

• Bachelor's degree in sciences or related field; MS/PhD preferred.
• 12+ years biopharmaceutical industry experience with 6+ years cell therapy.
• CMC project management experience leading teams and managing managers.

Responsibilities

• Translate strategy into project plans with deliverables and deadlines.
• Develop, drive and maintain detailed CMC plans and milestones.
• Facilitate CMC GAP assessment, risk analysis and strategy discussions.
• Lead data-driven decisions on continuation, acceleration, re-prioritization or redesign.
• Provide periodic status reports and coordinate documentation of deliverables.
• Escalate timeline slips and risks promptly with filing implications.
• Serve as the primary CMC point of contact for internal stakeholders.
• Lead and prioritize project managers supporting CMC projects.
• Own standards, templates and cadence for CMC Planning across the group.
• Communicate updates to team and executives with line of sight to issues and accomplishments.

Skills

Hands-on contributor

Cross-functional collaboration

Multi-tasking

Clear communication

Education

Bachelor's degree in sciences or related field

MS or PhD preferred

Job description

ProKidney Corp. is seeking a Director, CMC Project Management to lead CMC planning activities for late-stage and regulatory submissions, coordinating cross-functional teams to deliver a robust Integrated Project Plan.

The role requires deep CMC expertise in cell therapy, strong timeline management, and collaboration with Operations, Quality, Regulatory and Program Management to ensure timely BLA filing and inspection readiness.