Director, CMC Project Management — Biologics Leader

Cullinanoncology; Cambridge (MA); Hybrid; USD 200,000 - 260,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

Medical, dental, vision insurance

401(k) plan with employer match

Stock options

Paid time off

Job summary

Cullinan Therapeutics in Cambridge, MA, is seeking a Director of CMC Project Management to lead end-to-end CMC programs for biologics, partnering with the CMC Lead to align strategy and execution across development, manufacturing, regulatory, and quality.

This hands-on role requires 10+ years in CMC programs (biologics), PMP preferred, strong cross-functional leadership, and the ability to translate scientific plans into clear timelines and deliverables.

Qualifications

• MS or BS in a scientific or engineering discipline.
• PMP certification preferred.
• 10+ years of relevant experience, including 6 years managing CMC programs for biologics.
• Solid understanding of biologics CMC, including development, manufacturing, and regulatory requirements.
• Experience working with CDMOs and external partners.
• Experience applying AI tools to program management workflows.
• Familiarity with project management platforms and data visualization tools.
• Demonstrated success operating in a lean, operationally efficient environment.
• Ability to engage deeply with cross-functional teams and effectively partner with CMC Lead.

Responsibilities

• Own and drive integrated CMC project plans, timelines, and milestones across all development stages.
• Lead core CMC team meetings and ensure alignment, accountability, and follow-through actions.
• Work in close collaboration with the CMC Lead, forming a joint leadership model for each program.
• Support the CMC Lead by: Driving execution of agreed-upon strategy; Managing cross-functional dependencies; Ensuring decisions are implemented efficiently; Managing internal and external document reviews and approvals, including liaising with Finance on budgets; Monitor external partner performance and elevate risks as needed; Continuously assess program progress and proactively manage risks, gaps, and contingencies.
• Act as a primary program interface with CDMOs and major external vendors.
• Drive alignment on timelines, deliverables, and issue resolution.
• Integrate activities across Technical Operations (CMC, Quality, and Supply Chain), Regulatory, Finance, and Legal in a small-team environment.
• Leverage AI-enabled tools and scalable program management practices to strengthen planning, risk management, visibility, and execution across CMC programs.
• Prepare concise and data-driven updates for executive leadership, in partnership with the CMC lead.
• Clearly communicate CMC project status, risks, and mitigation plans.

Skills

Project management

Cross-functional leadership

AI tools

Data visualization

Vendor management

Agile

Executive communication

Education

MS or BS in scientific or engineering discipline

Tools

Project management platforms

Data visualization tools

AI tools

Job description

Cullinan Therapeutics in Cambridge, MA, is seeking a Director of CMC Project Management to lead end-to-end CMC programs for biologics, partnering with the CMC Lead to align strategy and execution across development, manufacturing, regulatory, and quality.

This hands-on role requires 10+ years in CMC programs (biologics), PMP preferred, strong cross-functional leadership, and the ability to translate scientific plans into clear timelines and deliverables.