The Role
Leads end-to-end CMC project execution for biologics, managing integrated plans, timelines, budgets, milestones, risks, and cross-functional dependencies. Partners with CMC Leads, Technical Operations, Quality, Supply Chain, Regulatory, Finance, Legal, CDMOs, and external vendors. Drives meetings, accountability, issue resolution, document approvals, executive reporting, and delivery from early development through clinical and commercial milestones. Applies AI-enabled tools, advanced analytics, and scalable project-management practices in a lean biotech environment.
Summary Generated by Built In
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.
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 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.
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.
Skills Required
- Bachelor’s or master’s degree in a scientific or engineering discipline
- PMP certification
- At least 10 years of relevant experience
- At least 6 years managing CMC programs for biologics
- Strong understanding of biologics CMC 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
- Success operating in a lean, operationally efficient environment
- Ability to engage with cross-functional teams and partner with a CMC Lead
- High ownership and execution leadership
- Ability to navigate ambiguity and shifting priorities
- Strong stakeholder-management and issue-resolution skills
- Ability to partner with technical leadership while maintaining execution ownership
- Strong technical fluency translating CMC discussions into plans, actions, timelines, and risks
- Clear, concise communication and strong executive presence
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The Company
What We Do
Cullinan Oncology is dedicated to creating new standards of care for patients with cancer. We innovate without borders to find the most promising clinic-ready cancer therapies, whether from our own discovery efforts or through exceptional engagement with our academic and industry partners. Anchored in a deep understanding of immuno-oncology and translational cancer medicine, we leverage our scientific excellence in small molecules and biologics to create differentiated ideas, identify unique targets, and select the optimal modality to develop transformative therapeutics across cancer indications
