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