Assoc. Director, Analytical Development

COMPANY:

At Bio Cryst, 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  or follow us on Linked In and Instagram.

The Associate Director of Analytical Development will provide scientific and operational leadership for analytical development and release testing activities supporting Bio Cryst'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 latestage 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.

• 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, latestage 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 current with evolving CMC and global regulatory strategies for biologics and small-molecule programs through literature and external networking, ensuring alignment with industry best practices and regulatory expectations.
• Provide mentorship, coaching, and leadership to internal and matrixed teams, contributing to a high-performing analytical organization.
• Partner with QC and Quality stakeholders to support method validations, method transfer, reference material qualification, deviation and OOS/OOT investigations, CAPA activities, and lifecycle management.
• All other duties as assigned.

• PhD in Chemistry, Biochemistry, or a related field with 8-12 years of experience in analytical development and QC supporting biologics programs from preclinical through latestage development.
• BS/MS with 10-12 years of relevant industry experience in analytical laboratories supporting biologics development and manufacturing.
• Strong technical expertise in biologics analytical sciences, including potency and impurities assays, life-cycle management methods, and data interpretation.
• Demonstrated experience supporting regulatory submissions and interacting with Quality and Regulatory functions.
• Proven ability to manage external partners and deliver results in a fast-paced biotech environment.
• Excellent written and verbal communication skills, including experience authoring technical reports and regulatory documentation.
• Experience with method development, validation, transfer, and GMP release and stability testing of biologics, including…