CMC Program Director: Planning & Cross-Functional Strategy

ProKidney Corp.; United States; Remote; USD 210,000 - 320,000; Full time

Job summary

ProKidney is seeking a Director, CMC Project Management to lead cross-functional planning for CMC activities supporting late-stage and commercial regulatory submissions. You will translate strategy into integrated project plans, manage milestones, and drive risk mitigation across manufacturing, quality, analytic and regulatory teams.

The ideal candidate brings 12+ years in biopharma with 6+ years in cell therapy, possesses strong PM leadership, and can coordinate with PMO and operations to

Qualifications

• Bachelor’s degree in sciences or related field; advanced degree preferred.
• 12+ years of biopharmaceutical experience with 6+ years in cell therapy.
• CMC project management experience in biotech/pharma focused on biologics/cell & gene therapy.
• Experience leading project managers or a PM team.

Responsibilities

• Translate CMC strategy into detailed project plans with deliverables and deadlines.
• Develop and maintain CMC Plan and Major Milestones across Technical Operations; track content draft and delivery dates.
• Facilitate CMC GAP Assessment, Risk Analysis and cross-functional decision making.
• Lead data-driven decisions on continuation, acceleration, or termination of projects.
• Represent CMC at project team meetings and coordinate with PMO.

Skills

Hands-on

Cross-functional collaboration

Multi-tasking

PM leadership

Education

Bachelor’s degree in sciences or related field

Advanced degree (MS, PhD) preferred

Job description

ProKidney is seeking a Director, CMC Project Management to lead cross-functional planning for CMC activities supporting late-stage and commercial regulatory submissions. You will translate strategy into integrated project plans, manage milestones, and drive risk mitigation across manufacturing, quality, analytic and regulatory teams.

The ideal candidate brings 12+ years in biopharma with 6+ years in cell therapy, possesses strong PM leadership, and can coordinate with PMO and operations to