Director, CMC - Formulations

About Codera Codera is a Tang Capital company that provides in-house, end-to-end drug development capabilities for its portfolio companies. Founded in 2002, Tang Capital is a life-sciences focused investment company that creates, acquires and finances companies that develop and commercialize pharmaceutical products. Position Summary The Director, CMC - Formulations will contribute to the oversight, planning and execution of Chemistry, Manufacturing and Controls (CMC) strategy, including drug product formulations, in support of Codera’s development programs. In collaboration with internal departments, such as nonclinical, clinical pharmacology and regulatory teams, the Director, CMC - Formulations will contribute to all aspects of chemistry, manufacturing and controls, including design of drug product formulations, oversight of vendors and production of regulatory documents. Essential Duties and Responsibilities Assist with the design and evaluation of drug product formulations, primarily small molecule formulations, to achieve specific pharmacokinetic (PK) goals Contribute to CMC and development strategy Manage relationships with various contract development and manufacturing organizations (CDMOs), analytical labs and contract research organizations (CROs) Assist with the clinical supply logistics Prepare, analyze and interpret analytical data that integrate into regulatory and intellectual property (IP) documents Draft, edit and review sections of regulatory and IP documents