Director, Supply Chain

COMPANY:

At BioCryst, we share a deep commitment to improving the lives of people living with complement-mediated and other rare diseases. For over three decades we've been guided by our passion for not settling for "ordinary" in our quest to develop novel medicines. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and 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, our European headquarters is in Dublin, Ireland 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 LinkedIn and Instagram.

JOB SUMMARY:

The Director, Supply Chain will support all supply chain operations, including CMO/Vendor management, distribution of product to 3PLs or other third parties and supply chain strategy. The individual in this leadership role will serve a critical role in overseeing the product supply chain to enable clinical development, planning and execution of the commercialization of BioCryst's products, including Orladeyo, BioCryst's first rare disease oral therapy to prevent hereditary angioedema attacks along with other pipeline products. This position will have significant interaction with Quality, Regulatory, Commercial, Global Supply Chain peers, and MS&T. This position will be based in North America and will be a remote position. #LI-Remote

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Oversees all internal and external operations related to the supply chain, including distribution, partner relationships, serialization, country-specific launch planning, logistics, and budget/forecasting.
• Provides central interface with assigned Partners/Suppliers/3PL's key personnel and BioCryst, including Business Development, Site Leadership, Supply Chain, Quality, Regulatory, Finance, MS&T, Supply Planning, Project Management, and other key functions.
• Collaborates with Quality, Regulatory, MS&T, and Supply Chain to ensure proper vendor management and on-time release of product.
• Manages overall relationship with assigned Partners/Suppliers/3PL's and related internal BioCryst resources to deliver key milestones/deliveries on time and ensures cost commitments are met.
• Reports routine KPIs for costs, quality, delivery and sustainability on Partners/Suppliers/3PL's.
• Leads identification of business improvements at assigned Partners/Suppliers/3PL's.
• Partners with key stakeholders to develop and implement Global supply chain strategy, supply/demand forecasting and scenario planning, shelf-life management, establishment and reporting of company and vendor metrics, including the establishment of necessary company infrastructure and policies/procedures.
• Ensures availability of materials in the Global supply chain, including strategic decision-making for each region (e.g. labeling strategy), and the maintenance of inventory at minimum acceptable levels.
• Supports and liaises with procurement and finance personnel regarding implementation/updates to the ERP system, the sourcing and supplying outside services, negotiating and contract management with CMOs, 3PLs, or other distribution partners, as needed.
• Works collaboratively with Clinical Supply Chain and other functions to support clinical, early access, compassionate use and transition to commercial supply chain, including coordination with finance/accounting on matters involving inventory, and with the Commercial Team to support commercial launch plans and forecasting to ensure adequate supply and inventory levels.
• Partners with commercial leads in each market to assist and drive supply chain security/continuity.
• Leads development of commercial product secondary packaging specifications in preparation for product launch presentation including package design, testing (as applicable), and artwork development/approval.
• Works collaboratively with MS&T and Regulatory to provide information required for submissions.
• Supports corporate compliance and legal requirements for the supply chain including manufacturer licensing (as applicable), GS1 certification maintenance, and serialization compliance.
• Prepares regular updates to management on key activities, risks, and proposed solutions.
• Leads the supply chain effort to support the launch into new markets
• Oversee Corporate Insurance and State Licensing programs
• Other duties as assigned.

EXPERIENCE & QUALIFICATIONS:

• Bachelor's degree in a scientific or engineering discipline
• 7-10 years' experience (or an equivalent combination of education and experience) of experience in positions related to supply chain, project management, and partner relationships.
• Very strong analytical, organizational, interpersonal, and communication skills.
• Experience working in a biotech or pharmaceutical company setting, managing multiple tasks and priorities.
• Demonstrated ability to be a team player and work effectively in a cross-functional team environment.
• Ability to recommend high-level decisions and to communicate effectively on a senior management level and externally.
• Must possess exceptional communication/presentation skills, self-motivation, exposure and/or knowledge of software programs including Microsoft Project, Power Point, MS Project, Interactive Response Technology (IRT), and Microsoft Office. Advanced skills with Microsoft Excel are preferred.
• General understanding of Technology Transfers, Process Validation, Drug Development Process, FDA/PMDA/EMA registrations and other related processes.
• Experienced working with third-party commercial providers including CMO's, Material Suppliers, and 3PL's preferred.
• Experience with Supply Chain ERP/MRP systems such as Oracle.

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.