CMC Project Leadership Director for Biotech Cell Therapy

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

Job summary

ProKidney is seeking a Director, CMC Project Management to lead cross-functional planning for late-stage CMC activities, coordinating with QA, RA, Operations and Regulatory to ensure on-time BLA submissions. The role manages timelines, dependencies and risk across manufacturing, analytical, and quality functions.

Ideal candidates will have 12+ years in biopharma, including 6+ years in cell therapy, and demonstrated leadership of PM teams, with a focus on data-driven decisions and strategic

Qualifications

• Bachelor's degree in sciences or related field; MS/PhD preferred.
• 12+ years in biopharmaceuticals with 6+ years in cell therapy.
• Experience leading PM teams or managers.

Responsibilities

• Translate strategy into project plans with deliverables and deadlines across cross-functional teams.
• Develop and maintain detailed CMC Plan and Major Milestones with timelines and risk mitigation.
• Facilitate CMC Gap Analysis, Risk Analysis and strategy discussions to drive cross-functional decisions.
• Lead data-driven decisions on continuation or reprioritization of projects and coordinate change management.
• Provide periodic status reports and document deliverables, highlighting risks and dependencies with consequences.
• Escalate timeline slips and risks promptly with regulatory implications.
• Serve as primary CMC contact for internal stakeholders and project meetings.
• Lead and prioritize PMs supporting CMC projects.
• Own standards and cadence for CMC Planning and IPP alignment.
• Communicate updates clearly to teams and executives.

Skills

Hands-on contributor

CMC depth

Cross-functional collaboration

Multi-tasking across pipelines

Project leadership

Executive communication

Education

Bachelor's degree in sciences or related field

MS/PhD preferred

Job description

ProKidney is seeking a Director, CMC Project Management to lead cross-functional planning for late-stage CMC activities, coordinating with QA, RA, Operations and Regulatory to ensure on-time BLA submissions. The role manages timelines, dependencies and risk across manufacturing, analytical, and quality functions.

Ideal candidates will have 12+ years in biopharma, including 6+ years in cell therapy, and demonstrated leadership of PM teams, with a focus on data-driven decisions and strategic