SVP, Global Manufacturing & Supply

COMPANY:

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 SVP, Global Manufacturing and Supply will oversee Bio Cryst's overall Clinical and Commercial Manufacturing/Supply & Distribution, Logistics/Import/Export and the Rapivab Commercial Business. These global functions are responsible for maintaining Clinical and Commercial Supply Chain from Raw Materials through Distribution, Transportation/Import/Export Management, Packaging Engineering, Manufacturing Science and Technology (MSAT), Master Data Management, and overall ERP/MRP system strategy. The individual in this global leadership role will be responsible for overseeing all the Manufacturing/Product Supply & Distribution related to Clinical and Commercial for all Bio Cryst's pipeline and commercial products.

Responsible for supply of commercial product revenue of $650M+ in 2026 growing to over $2B by 2030.

• Build and lead clinical and commercial manufacturing, supply & distribution organization responsible for ensuring the uninterrupted supply of clinical and commercial products within the product forecast and budget.
• Strategically guide and manage the Manufacturing Science and Technology (MSAT) team who support all technology transfers, process optimizations, process validations, and all routine technical support for our external manufacturing network.
• Plans and implements activities related to the timely, cost-effective procurement, inventory control, planning, quality control of production materials, distribution and logistics.
• 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.
• Lead and manage the Sales & Operations process for all Commercial Products. Ensures the availability of materials in the supply chain, as scheduled, and the maintenance of inventory at minimum acceptable levels working in concert with the Commercial, Finance, Quality, Regulatory and Supply Chain teams.
• Responsible for partnering with procurement for all goods/materials/services for Bio Cryst related to manufacturing, supply & distribution. This includes all direct materials, CMO/3PL agreements, Clinical and Commercial supply chain services, laboratory and testing services. Partner with Procurement on negotiating and managing all contracts for all CMOs, 3PLs, or other distribution partners, as needed.
• Owns and manages global manufacturing, supply and distribution risk management activities.
• Works collaboratively with other functions to support clinical and commercial supply chain, including coordination with finance/accounting on matters involving inventory-carrying costs, with Clinical Operations to maintain adequate supply of clinical trial material, with R&D for new product development.
• Manage the entire Rapivab commercial business including US and Australian commercial sales, API sales to strategic partners, and any/all United States stockpile agreements for Finished Goods and/or API. Current annual revenue is between $20M - $30M.
• Key member of Technical Operations Function along with Pharmaceutical Sciences, Quality and Regulatory functional areas. Provide oversight and decision-making for all critical technical issues related to Clinical and Commercial manufacturing, supply and distribution.
• Key leadership role supporting the launch planning and subsequent regional commercialization/distribution of Bio Cryst's products post regulatory approval.
• All other duties as assigned.

• Bachelor's degree in a related field with 15+ years' experience (or an equivalent combination of education and experience) in an executive supply chain management role within the pharmaceutical industry, with experience managing supply chain for…