Director, CMC Program Management

Reporting to the Executive Director, Portfolio and Program Management, as Director of CMC Program Management at GEMMABio, you will be the primary point of contact with our external manufacturing partner, supporting both Project and Alliance Management of the Partnership. You will work in close coordination with Executive Director Portfolio Management and VP, CMC Sciences to generate and implement the overall CMC project plan for GEMMA programs and ensure individual program plans are strategically integrated into the broader portfolio. This role is pivotal in ensuring timely, budget-conscious delivery of External Manufacturing activities and maintaining a strong collaboration with our CDMO partner.

Key Responsibilities

Program Oversight & Execution

• Develop and maintain the CMC program development plans to define, manage and communicate CMC deliverables and timelines in collaboration with the Project Manager and cross-functional program team (Preclinical, Clinical, Regulatory, QA) and ensure program timelines to organizational goals.
• Facilitate risk mitigation strategies and contingency planning for external manufacturing.
• Manage the CMC project budgets to ensure accurate forecasting, alignment with strategic priorities, and adherence to budgetary constraints.
• Ensure working group meetings are agenda-driven and focused on efficient decision-making.

External Collaboration & Alliance Management

• Serve as the primary point of contact for GEMMABio’s CDMO partner, ensuring alignment between both organizations.
• Oversee delivery of external manufacturing projects within scope and timelines, and act as a key escalation point for project-related issues to the Executive Director, Program and Portfolio Management and VP, CMC Sciences.

Operational Excellence

• As a key part of the Program Management team, lead strategic initiatives that impact program execution and portfolio success.
• Champion operational process improvements within R&D operations, working closely with CMC leadership to optimize meeting management and cross-functional workflows.

Performance & Team Leadership

• Develop and track Key Performance Indicators (KPIs) with PM team and CMC Sciences leadership.
• May supervise 1-2 reports

Qualifications

• Master's Degree (engineering or life sciences desired) and 5-7 years of applicable experience in program management is required.
• PMP or PMI certification beneficial but not required.
• Experience focused on Ph1/2 clinical stage AAV manufacturing; with late-stage clinical manufacturing experience, a plus.
• Experience in project management with the ability to develop clear action plans and execute.
• Experience managing multiple complex programs and demonstrated adeptness with dynamic prioritization of deliverables and resources.
• Ability to perform well under pressure and embrace dynamic environment.
• Strong analytical and critical thinking skills required.