VP, Drug Substance

BioCryst Pharmaceuticals; North Carolina; Remote; USD 300,000 - 520,000; Full time

Job summary

BioCryst Pharmaceuticals is seeking a Vice President, Drug Substance to lead enterprise strategy and execution across small-molecule and biologics portfolios. This senior leader will shape the function, drive externalization, and align CMC with regulatory expectations while partnering across Regulatory, MS&T, Quality, and Global Manufacturing.

The role oversees phase-appropriate development, scale-up, technology transfer, and commercial readiness, with emphasis on risk management, data

Qualifications

• Experience leading drug substance development across small-molecule and biologics.
• Strong regulatory and CMC submission knowledge.
• Proven ability to manage external CMOs and vendors.
• Familiarity with risk management and lifecycle management.

Responsibilities

• Define and drive the drug substance strategy in alignment with portfolio and corporate objectives.
• Oversee development, scale-up, validation readiness, and tech transfer for drug substance.
• Lead external partner governance and vendor relationships to ensure supply resilience.
• Build and develop a high-performing Drug Substance organization and manage the budget.

Skills

Leadership

Drug Substance

CMC strategy

Regulatory understanding

External partnerships

Budget management

Cross-functional collaboration

Job description

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 Vice President, Drug Substance is responsible for enterprise drug substance strategy and execution across BioCryst'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.

ESSENTIAL DUTIES & RESPONSIBILITIES:

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 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.

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.

LEADERSHIP COMPETENCIES

• 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

This is a primarily remote role, with a preference for Boston-area candidates who can periodically work from the office and meet with leadership.

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.