Director, CMC Project Management

Cullinan Therapeutics (NASDAQ: CGEM) is a clinical-stage biotech company developing potential first- or best-in-class, high-impact molecules in autoimmune diseases and cancer, where exceptional scientific expertise, strategic risk-taking, and rigorous decision-making unite to improve peoples’ lives.

We believe in a future where those living with autoimmune diseases and cancer spend less time managing their conditions and more time on what matters most. With deep expertise in immune modulation, Cullinan is where speed meets strategy to move profound innovations forward.

But movement isn’t just about speed — it’s about meaning. Our work is fueled by curiosity, determination, and compassion. We work side by side with our partners across the life science ecosystem to channel our collective potential into improving the lives of people living with autoimmune diseases and cancer.

Position 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 escalate 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.

Candidate Requirements

- MS or BS in a scientific or engineering discipline required.

- PMP certification is strongly preferred.

- Minimum 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 or advanced analytics 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.

- High ownership, execution leadership, and ability to drive results in a lean environment with a lean, but evolving structure.

- Agile and resourceful, comfortable navigating ambiguity and shifting priorities.

- Strong stakeholder management and issue resolution skills.

- Ability to partner effectively with technical leadership while maintaining execution ownership

- Strong technical fluency with the ability to translate CMC discussions into clear plans, actions, timelines, and risks.

- Clear, concise communicator with strong executive presence.

Cullinan Therapeutics is proud to be an Equal Opportunity Employer. We are committed to creating an inclusive and diverse environment for all employees and applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.