VP, Drug Substance

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.comor follow uson LinkedInand Instagram.

Drug Substance Strategy and Portfolio Leadership

* 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 escalate 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.

Process Development, Scale-Up, and Commercial Readiness

* 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 suitability for regulatory submission.

* Partner with other CMC functions to establish phase-appropriate development plans, control strategies, comparability approaches, validation strategies, and responses to regulatory questions.

* Promote compliance with applicable cGMP requirements and global regulatory expectations while maintaining a culture of scientific rigor, data integrity, quality risk management, and continuous improvement.

External Partner and Manufacturing Oversight

* Lead the technical evaluation, selection, governance, and performance oversight of contract development and manufacturing organizations and other drug substance partners in collaboration with MS&T and Global Manufacturing.

* Build strategic relationships with external partners to ensure clear accountability, effective knowledge transfer, reliable delivery, inspection readiness, and long-term supply resilience.

* Ensure technology transfers are appropriately planned, documented, executed, and supported by process knowledge, risk assessments, and fit-for-purpose control strategies.

Organization, People, and Financial Leadership

* Build, lead, mentor, and develop a high-performing drug substance organization with the capabilities required for the evolving portfolio.

* Define the future organizational design, talent strategy, and use of internal and external resources for the Drug Substance function.

* Foster an inclusive, accountable, and collaborative culture that supports sound technical decision-making, effective delegation, and development of scientific and leadership talent.

* Develop, own, and manage the drug substance operating budget, external manufacturing and development spend, and resource forecasts; ensure disciplined financial performance and transparent trade-off decisions.

* Represent Drug Substance and, when appropriate, the broader Pharmaceutical Sciences organization in internal governance forums and with external stakeholders.

* PhD in chemical engineering, biochemical engineering, biochemistry, chemistry or a related technical discipline, with substantial relevant industry experience; or an equivalent combination of advanced education and experience.

* Typically, 15 or more years of progressive experience in drug substance development, scale-up, technology transfer, and manufacturing, including significant leadership responsibility in an industrial setting.

* Demonstrated experience leading drug substance programs from early development through late-stage development and commercial readiness. Experience spanning both biologics and small-molecule modalities is strongly preferred; deep expertise in at least one modality with demonstrated ability to lead across the other is required.

* For biologics, strong knowledge of cell line, upstream, downstream, scale-up, process characterization, viral safety, comparability, validation, and commercial manufacturing considerations. For small molecules, strong knowledge of API route and process development, scale-up, impurity control, solid-state or physical-form considerations, process safety, validation, and commercial manufacturing considerations.

* Experience providing technical oversight of external development and manufacturing organizations, including partner selection, governance, technology transfer, troubleshooting, performance management, and inspection readiness.

* Experience preparing, reviewing, or approving drug substance CMC content for U.S. and global regulatory submissions and responding to health-authority questions.

* Strong knowledge of cGMP manufacturing, quality risk management, process validation, change management, comparability, and applicable FDA, EMA, ICH, and other global regulatory expectations.

* Demonstrated success building and leading teams, developing talent, shaping organizational capabilities, and influencing across a matrixed organization.

* Ability to translate complex scientific and operational issues into clear strategic choices, risk-based recommendations, and executable plans.

* Excellent written and oral communication, executive presence, relationship-building, negotiation, and presentation skills.

* Ability to travel domestically and internationally based on business needs.

* Enterprise and portfolio thinking

* Scientific and technical judgment

* Operational execution and accountability

* Quality and compliance mindset

* Cross-functional influence and collaboration

* Talent development and organizational leadership

* External partnership and vendor governance

* Financial and resource stewardship

The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.

BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.