CMC Project Manager

Position Summary

The CMC Project Manager is responsible for Chemistry, Manufacturing, and Controls (CMC) program management from early development through commercialization. This role serves as the central coordinator across Technical Operations, Process Development, Analytical Development, Formulation Development, Manufacturing, Quality, Regulatory, Supply Chain, and external partners to ensure timely delivery of program milestones. This role is with a well financed Third Rock Ventures stealth company.

The ideal candidate possesses a strong technical foundation with a minimum of 8 years of hands-on experience in Process Development, Manufacturing Sciences, Technical Operations, Analytical Development, or related functions prior to transitioning into project management. This technical expertise enables effective risk assessment, decision-making, and communication across multidisciplinary teams.

Key Responsibilities

CMC Program Management

• Manage cross-functional CMC development programs from preclinical through commercial stages; develop and maintain integrated project plans, timelines, RAID (risks, assumptions, issues, decisions) and action logs.
• Drive execution of critical path activities, ensure mitigation strategies aligned with mitigation program timelines.
• Facilitate cross-functional team meetings; ensure project deliverables on time.
• Build program management best practice with tools and process as part of continuous improvement in operation and business.

CMC Development Oversight

• Coordinate activities across Process Development, Analytical Development, Formulation Development, Manufacturing, Quality Control, Quality Assurance, Regulatory Affairs, and Supply Chain.
• Monitor progress of technical development, technology transfer, and manufacturing campaigns.
• Support preparation and execution of IND, CTA, or equivalent regulatory submissions.
• Ensure readiness for key development milestones, including GMP manufacturing and clinical supply production activities.

External Partner Management

• Coordinate activities with CDMOs, CROs, testing laboratories, raw material suppliers, and manufacturing partners.
• Track external deliverables, timelines, and performance metrics.
• ics.Facilitate issue resolution and escalation with external partners when necessary.

Stakeholder Communication

• Prepare project status updates, dashboards, and executive summaries for leadership.
• Communicate project progress, risks, budget status, and key decisions to stakeholders.
• Support governance meetings and portfolio review processes.

Qualifications

Education

• Bachelor's degree in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, Biotechnology, Biology, or related scientific discipline required.
• Advanced degree (MS, PhD) preferred.

Experience

• Minimum 8 years of hands-on technical experience in pharmaceutical, biotechnology, biologics, cell therapy, gene therapy, radiopharmaceutical, or peptide development prior to assuming project management responsibilities
• Minimum 3 years of project management experience leading cross-functional CMC programs.
• Demonstrated experience supporting development programs from early-stage development through clinical and/or commercial manufacturing.
• Experience managing external CDMOs and development partners.
• Knowledge of GMP regulations, CMC development processes, and regulatory requirements.

Preferred Experience

• Experience with biologics, antibodies, ADCs, peptides, or advanced therapeutic modalities.
• Experience supporting IND/CTA filings
• PMP certification or equivalent project management training is preferred.
• Proficient user of project management software (MS project and Smartsheet).

Key Competencies

• Strong technical understanding of pharmaceutical development and manufacturing.
• Excellent project planning and organizational skills.
• Ability to translate complex technical information into actionable project plans.
• Strong leadership and influence skills without direct authority.
• Excellent verbal and written communication.
• Proactive risk identification and problem-solving capabilities.
• Ability to thrive in a fast-paced, dynamic development environment.
• Strong stakeholder management and cross-functional collaboration skills.

This is a hybrid role. Our team is located in San Francisco, Boston and Shanghai. The ideal candidate would be available to be in office 1 day per week and travel to other locations for meetings as needed.