Director, CMC Project Management

Cullinan Therapeutics, Inc.; Cambridge (MA); Hybrid; USD 200,000 - 260,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

Insurance (medical, dental, vision)

401(K) with match

Stock options

Employee stock purchase plan

PTO

Paid parental leave

Cell phone reimbursement

Tuition reimbursement

Job summary

Cullinan Therapeutics, Inc. in Cambridge, MA seeks a Director of CMC Project Management to lead end-to-end CMC programs for biologics in a lean biotech setting. You will own timelines, budgets, and cross-functional delivery with the CMC Lead, spanning development, manufacturing, quality and regulatory work.

The role requires strong communication with executives, risk management, and collaboration with CDMOs and external partners; experience with AI-enabled PM tools is a plus.

Qualifications

• MS/BS in 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 PM 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.
• Drive execution of strategy and manage cross-functional dependencies.
• Ensure decisions are implemented efficiently and monitor budgets.
• Act as primary interface with CDMOs and major external vendors.
• Integrate activities across Technical Operations, Regulatory, Finance and Legal.
• Leverage AI-enabled tools to strengthen planning, risk management, and execution.
• Prepare concise updates for executive leadership and communicate status.

Skills

PMP certification

Project management leadership

Cross-functional collaboration

AI tools for PM

Biologics CMC knowledge

Vendor management

Regulatory awareness

Executive communication

Education

MS or BS in a scientific or engineering discipline

Tools

PM platforms

Data visualization tools

Job description

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 isnt just about speed - its 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.

The Director of CMC Project Management will support end-to-end CMC project execution for biologics within a lean, fast-paced biotech environment. This individual will operate as a hands-on project manager, partnering closely with the CMC Lead for each program to integrate strategy and execution across process development, manufacturing, supply chain, quality, and regulatory functions.

In this model, the CMC Project Manager is responsible for timeline management, budgeting, and delivery of strategic objectives, while the CMC Lead is responsible for strategy and scientific direction. Together, this tight partnership between technical leadership and project execution should ensure that strong scientific strategy is translated into clear plans, disciplined execution, and timely delivery, enabling the organization to efficiently advance programs and with high quality from early development through clinical and commercial milestones.

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 escalates risk 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.

Location

This position may be remote with occasional travel to the office or hybrid/based at our corporate offices in Cambridge, MA.

Compensation

The salary range for this role is $200,000 - $260,000. The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. We may ultimately pay more or less than the posted range, and the range may be modified in the future. Actual base salary pay for the role may vary within the range based on several factors including, but not limited to, geographic location, candidate experience, skills, relevant education/qualifications, competencies, external market, internal equity, business needs and/or other job-related factors permitted by law.

Additional compensation/benefits include annual bonus opportunity (20% of salary), annual equity awards, medical, dental, vision, life and 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.

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.