Remote CMC Program Director, Biologics | Fast-Paced PM

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

Benefits offered by this job

Annual bonus

Equity awards

401(k) match

Stock options

Tuition reimbursement

Paid time off & holidays

Job summary

Cullinan Therapeutics, a clinical-stage biotech company, seeks a Director of CMC Project Management to lead end-to-end CMC program execution for biologics. You will partner with the CMC Lead to align strategy with execution across development, manufacturing, supply chain, quality, and regulatory functions.

The role emphasizes tight collaboration, risk management, and data-driven updates to leadership.

Qualifications

• MS or BS in a scientific or engineering discipline.
• PMP certification 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 PM workflows.
• Familiarity with project management platforms and data visualization tools.
• Demonstrated success operating in a lean, operationally efficient environment.

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 strategy and managing cross-functional dependencies.
• Manage 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, Regulatory, Finance, and Legal.
• Leverage AI-enabled tools and scalable program management practices.
• Prepare concise updates for executive leadership with the CMC lead.
• Clearly communicate CMC project status, risks, and mitigation plans.

Skills

CMC program management

Biologics CMC

PMP certification

Lean operations

AI in PM

Cross-functional leadership

Stakeholder management

Executive communication

CDMOs experience

Data visualization tools

Education

MS or BS in science/engineering

Tools

PM platforms

Data visualization tools

Job description

Cullinan Therapeutics, a clinical-stage biotech company, seeks a Director of CMC Project Management to lead end-to-end CMC program execution for biologics. You will partner with the CMC Lead to align strategy with execution across development, manufacturing, supply chain, quality, and regulatory functions.

The role emphasizes tight collaboration, risk management, and data-driven updates to leadership.