Assoc. Director, Analytical Development

COMPANY: At BioCryst, we share a deep commitment to improving the lives of people living with hereditary angioedema (HAE) and other rare diseases. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and injectable protein therapeutics. Our global headquarters is in Durham, North Carolina, we have a regional office in Boston, Massachusetts, and our employees span the globe across sites in multiple countries. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit our website at www.biocryst.com  or follow us   on LinkedIn  and Instagram . JOB SUMMARY: The Associate Director of Analytical Development will provide scientific and operational leadership for analytical development and release testing activities supporting BioCryst’s biologics portfolio. This role is responsible for overseeing phase‑appropriate analytical method development, qualification, transfer and execution at external Contract Development and Manufacturing Organizations (CDMOs) and Contract Test Laboratories (CTLs), with emphasis on potency and impurities assays for biologics. The Associate Director will work cross‑functionally with Drug Substance, Drug Product, Quality, and Regulatory Affairs teams to ensure product quality, robust analytical strategies, and timely support of clinical and late‑stage development programs. This position requires strong technical expertise in biologics analytical sciences, a data‑driven mindset, and the ability to operate effectively in a fast‑paced, collaborative biotech environment. ESSENTIAL DUTIES & RESPONSIBILITIES: Provide scientific and operational leadership for analytical development across biologics programs from early development through late stage and commercialization, primarily at external partners. Lead analytical strategies for potency, impurities and other release assays to support biologics development, clinical supply, late‑stage development, and commercialization readiness. Drive interpretation and application of product quality data to define CQAs, QTPPs, control strategies, and characterization packages supporting regulatory submissions and process changes. Lead analytical method development, qualification, and testing activities at CDMOs and contract test laboratories, including potency, purity, identity, safety, and other release and stability assays for biologics. Author and review high‑quality analytical reports, technical summaries and other documentation to support product development. Author and review analytical sections of CMC regulatory filings and communicate analytical risks, timelines, and data interpretations to internal teams and external partners. Build and maintain strong relationships with CDMO and CTL partners, applying metrics to manage risk, prioritize work, and drive continuous improvement. Stay…