Director, CMC Project Management - Biologics (Remote)

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, 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.