Note: The job is a remote job and is open to candidates in USA. Cullinan Therapeutics is a clinical-stage biotech company developing potential first- or best-in-class molecules for autoimmune diseases and cancer. The Director of CMC Project Management will lead end-to-end CMC project execution for biologics, managing integrated plans, timelines, budgets, risks, external partners, and cross-functional coordination from early development through clinical and commercial milestones.
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
Skills
- MS or BS in a scientific or engineering discipline required
- 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
- This position may be remote with occasional travel to the office or hybrid/based at our corporate offices in Cambridge, MA
- PMP certification is strongly preferred
Benefits
- This position may be remote with occasional travel to the office or hybrid/based at our corporate offices in Cambridge, MA.
- Annual bonus opportunity (20% of salary)
- Annual equity awards
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- Disability insurance
- 401(K) plan with employer match
- Stock options
- Employee stock purchase plan
- Flexible non-accrual paid time off
- Paid holidays
- End-of-year shut down
- Cell phone reimbursement
- Tuition reimbursement
- Paid parental leave
Company Overview