Sr. Commercial Supply Chain Operations Manager

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 us on LinkedIn and Instagram. 

JOB SUMMARY:

The Sr. Commercial Supply Chain Operations Manager will support the overall relationship with our Contract Manufacturing Operations (CMO), Material Suppliers and 3rd Party Logistics Providers (3PL) who support Clinical Drug Development, MS&T, and Commercial Production for BioCryst. The individual in this key supply chain role will provide oversight of the product supply chain to enable clinical development and plan for the commercialization of BioCryst’s products. The individual should bring energy every day and work collaboratively to make hope a reality for patients suffering from rare and orphan diseases. #LI-Remote

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Manages overall relationship with assigned CMOs/Suppliers/3PLs and related internal BioCryst resources to deliver key milestones/deliveries on time and ensures cost commitments are met
• Provides central interface with assigned CMOs/Suppliers/3PLs key personnel and BioCryst, including Business Development, Site Leadership, Supply Chain, Quality, Regulatory, Finance, MS&T, Planning, Project Management, and other key functions
• Provides data for budgeting, forecasting and purchase order management ensuring appropriate inputs to Supply Chain Planning and recommendations to senior management for modifications that could benefit the organization
• Reports routine KPIs for costs, quality, delivery and sustainability
• Leads identification of business improvements at assigned CMOs/Suppliers/3PLs
• Ensures quality and regulatory compliance of assigned CMOs/Suppliers/3PLs by leading a cross-functional team
• Leads initiative implementation following appropriate contract amendments/changes
• Continually evaluate and benchmark CMOs/Suppliers/3PLs performance against other external and internal options and provide suggestions for process improvements
• Provides forecasts to CMOs, confirms manufacturing capability and delivery dates, and escalates any concerns/issues to management
• Supports special projects at CMOs/Suppliers/3PLs that pertain to Supply Chain (e.g., serialization, package design)
• Coordinates with MS&T to ensure that relevant process improvements are being made to support ongoing supply chain development
• Coordinates with MS&T and QA to ensure that relevant batch documentation and batch tree is kept up to date and provides suggestions for process improvements
• Coordinates with QA and legal to ensure that relevant agreements and documentation are in place to support ongoing vendor qualification and legal status (e.g., Quality Agreements, Commercial Supply Agreements/Amendments, Confidentiality Agreements)
• Generate purchase orders and perform invoice reconciliation in collaboration with finance and any other relevant team members
• Perform system transactions and ensure the timely and accurate order fulfillment, documentation, closure of outstanding issues and effective inventory system
• Perform the coordination and monitoring of all inbound and outbound shipments, including coordination of import/export, finance, and legal reviews of documentation
• Monitor inventory levels at all stages of assigned supply chain and proactively suggests solutions regarding expiry and re-supply needs across inventory
• Leads global artwork creation, approval, and revisions including generation of technical drawings, coordination with graphic design agency, and generation/approval of master artwork and proofs
• Supports late-stage development projects with items pertaining to supply chain, including oversight and proactive suggestions to the cross-functional development team.
• Supports commercial trade dress decision making for late-stage development projects and life-cycle trade dress updates for existing products
• Identifies and supports life-cycle supply chain improvements for existing commercial products
• Provides updates and presentations to management, including S&OP and other leadership meetings.
• Provides guidance and mentorship to junior level staff.
• Other duties as assigned

EXPERIENCE & QUALIFICATIONS:

• Bachelor’s Degree in Supply Chain Management, Business Administration, Quality, Engineering, Mathematics, Business Analytics, or similar education required
• 7-10 years of experience with experience in biotech/pharmaceutical manufacturing industry with solid dose and/or sterile products background preferred
• Strong analytical, mathematical, and problem-solving skills
• Demonstrated ability to be a leader, a team player and work effectively in cross functional team environment
• Must possess exceptional communication/presentation skills, self-motivated, 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.
• Experienced working with third-party commercial providers including CMOs, Material Suppliers, and 3PLs preferred.
• General understanding of Technology Transfers, Process Validation, Drug Development Process, FDA/PMDA/EMA registrations, and other related processes.
• Experience with Supply Chain ERP/MRP systems such as Oracle and SAP.

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.