Remote VP, Drug Substance Strategy & Externalization

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

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