VP, Commercial Manufacturing & Supply

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, led by the efforts of our team of expert scientists in our Discovery Center of Excellence in Birmingham, Alabama. Our global headquarters is in Durham, North Carolina 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 uson LinkedInand Instagram.

JOB SUMMARY:

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Lead a high-performing global manufacturing and supply team responsible for planning, manufacturing and distributing our global commercial products.
• Provides executive leadership for global commercial supply chain operations supporting solid oral dosage, biologics, and sterile injectable products, including pre-filled syringes and auto-injector combination products.
• Leads supply and demand planning, inventory strategy, shelf-life management, and scenario planning to ensure uninterrupted global product supply at optimal inventory levels.
• Oversees and optimizes contract manufacturing organizations (CMOs) supporting raw materials/starting materials, drug substance, drug product, device assembly, labeling, and packaging for solid dose, biologic, and injectable platforms.
• Partners with Manufacturing Science and Technology (MSAT) to support technology transfers, process validation, continued process verification, stability programs, and lifecycle management activities.
• Leads global launch readiness and country-specific supply planning, including serialization, cold-chain logistics, combination product requirements, and regional distribution strategies.
• Owns and drives the Sales & Operations Planning (S&OP) process in partnership with Commercial, Finance, Quality, and Data Insights teams.
• Collaborates with Pharmaceutical Sciences, Quality and Regulatory to support global submissions, post-approval changes, and inspection readiness for solid dose, biologic, sterile injectable, and combination products.
• Ensures compliance with global regulatory, quality, and distribution requirements including manufacturer licensing, state distribution licenses, GS1 certification, serialization, and combination product regulations.
• Provides strategic oversight of raw/starting materials, API/Drug Product and primary/secondary packaging operations, including blister, bottle, vial, pre-filled syringe, and auto-injector assembly and packaging.
• Manages performance, contracts, and strategic relationships with CMOs, suppliers, and 3PL partners to ensure quality, service, and cost objectives are achieved.
• Partners cross-functionally with Procurement, IT, Finance, and Logistics on ERP systems, master data governance, and continuous improvement initiatives.
• Prepares and presents regular updates to senior leadership on supply performance, capacity planning, risks, and mitigation strategies.
• Owns and manages global commercial supply chain risk management activities.
• Supports corporate compliance, audit readiness, and regulatory inspections across commercial supply chain operations.
• Performs other duties as assigned.

EXPERIENCE & QUALIFICATIONS:

• Bachelor's degree in Supply Chain, Engineering, Pharmaceutical Sciences, Life Sciences, or a related discipline; advanced degree preferred.
• 15+ years of progressive experience in commercial pharmaceutical or biotechnology manufacturing and supply leadership roles.
• Demonstrated experience supporting solid oral dosage forms, biologics, and sterile injectable products, including pre-filled syringes and auto-injector drug-device combination products.
• Extensive experience managing CMOs for drug substance, drug product, device assembly, packaging, labeling, and global cold chain distribution.
• Strong working knowledge of Pharmaceutical Sciences, including technology transfer, process validation, stability, and lifecycle management.
• Experience supporting global product launches and sustaining supply in a multi-region commercial environment.
• Comprehensive understanding of FDA, EMA, PMDA, and global regulatory requirements for solid dose, biologics, sterile injectables, and combination products.
• Proven ability to lead cross-functional teams and influence senior leadership through clear, data-driven communication.
• Advanced analytical, organizational, interpersonal, and presentation skills.
• Experience with ERP and supply chain planning systems such as SAP, Oracle, Veeva, or similar platforms.
• Demonstrated ability to manage multiple priorities in a fast-paced, highly regulated environment.

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.