Associate Director, Process Chemistry

Job description

Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. Position Summary: The Associate Director, Process Chemistry will lead small-molecule process development and manufacturing efforts supporting clinical-stage drug substance programs, with a primary focus on early-phase clinical manufacturing. This role spearheads the design, development and technical oversight of synthetic routes for programs ranging from IND-enabling studies through Phase 2, ensuring that Drug Substance supply is delivered with speed, quality, and phase-appropriate controls. The Associate Director will work closely wit...