Associate Director, Chemical Development

Associate Director, Chemical Development

About the Role

The Associate Director, Chemical Development will support the strategic planning and execution of CMC activities related to drug substance development and manufacturing at CMOs from preclinical through commercialization. Reporting to the Director of Chemical Development, this role will provide technical and operational leadership for assigned programs and collaborate closely with Technical Operations, Pharmaceutical Sciences, Analytical Development, Quality, Regulatory Science, and Supply Chain to support the continuous supply of clinical and commercial products.

Let’s talk about some of the key responsibilities of the role:

• Manage API operations across assigned CMC programs and ensure operational plans align with regulatory, program, and corporate strategies. Oversee the manufacture of clinical and commercial drug substance at CMOs and drive adherence to project timelines, quality requirements, and supply objectives. Build and maintain effective working relationships with external manufacturing partners.
• Partner with CMOs to plan and execute manufacturing initiatives, including CMO site selection, technology transfer, scale-up, process development and optimization, validation, and clinical and commercial production.<