Director, Gene Therapy CMC Lead

About the role

We’re looking for a Director, Gene Therapy CMC Lead on the Manufacturing, Science & Technology team to help us expand what’s possible for patients with serious diseases. Reporting to the Sr Director Manufacturing, Science & Technology you’ll serve as CMC Lead providing strategic and operational leadership for the Chemistry, Manufacturing, and Controls (CMC) development of a gene therapy program from early development through clinical development, regulatory submission, and commercialization readiness. This individual will serve as the overall CMC integrator and single point of accountability, coordinating activities across Process Development, Analytical Development, Manufacturing, Quality, Regulatory CMC, Supply Chain, and external CDMO/CRO partners. The CMC Lead will develop and execute a comprehensive CMC strategy appropriate for the program's stage, modality, and regulatory pathway, ensuring that the manufacturing process, analytical control strategy, materials, facilities, and CMC documentation collectively support clinical development and regulatory.

Responsibilities

• In this role, you’ll have the opportunity to develop and execute the overall CMC strategy and integrated development plan for the gene therapy program.
• Lead cross-functional CMC activities across Process Development, Analytical Development, Manufacturing, Quality, Regulatory, and Supply Chain.
• Establish product and process control strategies, including CQAs, CPPs, specifications, and analytical requirements.
• Oversee process development, scale-up, technology transfer, manufacturing readiness, and process characterization.
• Provide strategic oversight of analytical development, product characterization, potency, and release testing.
• Lead CMC activities with internal teams and external CDMOs/CROs, ensuring execution against program timelines and milestones.
• Partner with Regulatory Affairs on CMC strategy, regulatory interactions, and preparation of IND/CTA and marketing application submissions.
• Identify and mitigate technical, manufacturing, supply, and regulatory risks impacting the program.
• Lead CMC decision-making, governance, and communication of program status, risks, and critical issues to senior management.

Requirements

You have a PhD along with 5 years of experience in biopharmaceutical development, gene therapy or viral-vector programs OR You have a Master’s along with 8 years