Associate Director, Drug Substance Manufacturing & Development

We are seeking an Associate Director responsible for phase-appropriate small molecule drug substance development. This critical hire will bring a strong process development background and experience managing external vendors and will define and execute on a strategy for synthetic route, process optimization, site transfer, scale-up and validation. Responsibilities include being a subject matter expert for all aspects of drug substance process and controls, managing development and manufacturing activities at drug substance CDMOs, and leading small molecule drug substance route selection/evaluation and process control development. Responsibilities also include authoring and reviewing regulatory filings, providing guidance as a subject matter expert, and providing on-site support at external suppliers.