VP, Drug Substance

Role: Vice President, Drug Substance overseeing enterprise strategy and execution for BioCryst’s small-molecule and biologics portfolio. Responsibilities: lead end-to-end process development, scale-up, manufacturing readiness, technology transfer, process validation, and commercialization; shape organizational strategy, capabilities, and external partnerships; manage regulatory submissions and compliance; build and develop a high-performing team; oversee budgets and resource planning. Requirements: PhD in chemistry, biochemistry, chemical or biochemical engineering, or related field; 15+ years in drug substance development and manufacturing, with significant leadership; deep expertise in biologics (cell line, upstream/downstream processing) and/or small molecules (API development, process scale-up, validation); proven experience with external vendor governance, regulatory interactions, and global cGMP standards; strong strategic, operational, and communication skills. High-Value: biologics and small-molecule modalities; from early development through late-stage validation and commercialization; global regulatory experience; remote with periodic Boston-based work; domestic and international travel. Collaboration: partners with Analytical and Drug Product Development, Manufacturing, Regulatory, and external vendors.