Remote CMC Program Director: Planning & Delivery

ProKidney Corp.; Winston-Salem (NC); Remote; USD 180,000 - 230,000; Full time

Job summary

ProKidney Corp. is seeking a Director of CMC Project Management to lead CMC planning for late-stage and commercial submissions. You will coordinate cross-functional teams, manage IPP inputs, and drive timely CMC activities through BLA, PLI, and approvals.

The role requires hands-on leadership across manufacturing, quality, analytical and regulatory areas with a focus on risk mitigation. You will report to the VP, Technical Operations Strategy, with dotted line to PMO, and work closely with

Qualifications

• Bachelor's degree in sciences or related field is required; advanced degree preferred.
• Must have 12+ years of biopharma experience with 6+ years in cell therapy.
• Experience leading project management teams and cross-functional CMC programs.

Responsibilities

• Translate strategy into detailed CMC plans with deliverables and deadlines.
• Develop and maintain CMC plans and milestones across Technical Operations.
• Facilitate CMC Gap Assessments, risk analyses, and cross-functional decisions.
• Lead data-driven decisions on continuation, reprioritization or termination of projects.
• Provide periodic status updates and manage documentation of deliverables and risks.
• Escalate timeline slips and risks with clear consequences.
• Serve as primary CMC point of contact for internal stakeholders.
• Lead and prioritize project managers supporting CMC projects.
• Own standards and cadence for CMC Planning and IPP input.
• Communicate updates to team members and executives.

Skills

Hands-on

CMC depth

Cross-functional collaboration

Multi-tasking

Risk identification

Education

Bachelor's degree in sciences

Advanced degree (MS, PhD) preferred

Job description

ProKidney Corp. is seeking a Director of CMC Project Management to lead CMC planning for late-stage and commercial submissions. You will coordinate cross-functional teams, manage IPP inputs, and drive timely CMC activities through BLA, PLI, and approvals.

The role requires hands-on leadership across manufacturing, quality, analytical and regulatory areas with a focus on risk mitigation. You will report to the VP, Technical Operations Strategy, with dotted line to PMO, and work closely with