VP, Drug Substance

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 Vice President, Drug Substance is responsible for enterprise drug substance strategy and execution across Bio Cryst's small-molecule and biologics portfolio. The role provides end-to-end leadership for drug substance process and technology development, scale-up, manufacturing readiness, technology transfer, process characterization and validation, and commercialization. This leader ensures that phase-appropriate, robust, compliant, and commercially viable drug substance processes are advanced in alignment with program objectives and global regulatory expectations.

As the senior functional leader for Drug Substance, the Vice President will shape the function's strategy, organizational capabilities, externalization model, resource plan, and technology roadmap. The role partners closely with Analytical Development, Drug Product Development, MS&T, Quality, Regulatory, Global Manufacturing and Supply Chain, while serving as the primary technical leader for external drug substance development and manufacturing partners.

• Own and execute the drug substance strategy across small-molecule active pharmaceutical ingredients and biologic drug substances, from candidate selection and early development through late-stage development, validation, launch readiness, commercialization, and lifecycle management.
• Align drug substance priorities, deliverables, timelines, budgets, and resources with portfolio and corporate objectives; identify critical dependencies and elevate risks with clear mitigation plans.
• Create, maintain, and curate the drug substance technology roadmap to guide platform capabilities, process innovation, digitalization strategies, externalization strategy, capacity planning, and investment priorities.
• Provide drug substance leadership in program teams, portfolio reviews, due diligence, regulatory interactions, indication expansion assessments, and technology or innovation evaluations; collaborate with Analytical Development and Drug Product Development to ensure integrated CMC strategies and aligned program execution.

• Oversee phase-appropriate process development and manufacturing readiness, including biologics cell line and upstream and downstream process development, and small-molecule route, process, and control-strategy development.
• Provide technical oversight for scale-up, process characterization, process validation readiness, process performance qualification, technology transfer, and manufacturing support. Lead drug substance clinical-supply strategy and execution through pivotal clinical development and collaborate with MS&T and Global Manufacturing and Supply after validation to support commercialization, continued process verification, and lifecycle management.
• Ensure drug substance processes are scientifically sound, reproducible, scalable, cost-conscious, and capable of consistently delivering material with the intended quality profile.
• Lead technical risk assessments and assess the appropriate level of risk acceptance, mitigation, and contingency planning for significant drug substance issues.
• Drive timely investigation and resolution of complex processes, manufacturing, comparability, raw-material, and supply risks with internal teams and external partners.
• Provide strategic and operational oversight for drug substance CMC content in regulatory submissions and health-authority responses, including INDs, IMPDs, NDAs, BLAs, MAAs, and relevant post-approval submissions.
• Review and approve drug substance development reports, manufacturing and validation documentation, and GMP-related submission content for scientific accuracy, consistency, compliance, and…