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 us on LinkedIn and Instagram.
ESSENTIAL DUTIES & RESPONSIBILITIES:
- Oversees all internal and external supply operations related to commercial distribution, specialty pharmacy operations, S&OP processes, strategic long-term planning and key partner relationships (NeoPharmed Gentili, Torii/Orphan Pacific, Kaken, etc.)
- Collaborates closely with Logistics function to ensure all product movements are executed using qualified vendors, validated lanes and utilize intermediate warehouses/free trade zones (FTZ) to ensure compliant and optimized shipping/storage.
- Collaborates with Quality, Regulatory, Finance and Pharmaceutical Sciences to ensure proper vendor management and on-time movement of product.
- Manages overall S&OP and Capacity Planning processes interfacing with Commercial, GMS, Finance, Pharmaceutical Science and Global Partners (NG, Kaken, OP/Torii, etc.) to ensure accurate planning, inventory management and timely supply.
- 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.
- Works collaboratively with GMS leadership, Global Technical Operations leadership and IT to ensure master data and system interfaces are maintained. Position owns master data governance and oversight for GMS.
- Reports routine KPIs for costs, quality, delivery and sustainability on Partners/Suppliers/3PL’s/Specialty Pharmacies.
- Leads identification of business improvements at assigned Partners/Suppliers/3PL’s/Specialty Pharmacies.
- Partners with key stakeholders to develop and implement Global Manufacturing 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 Manufacturing Supply Network, including strategic decision-making for each region 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 3PLs, Specialty Pharmacies or other distribution partners, as needed.
- Partners with commercial leads in each market to assist and drive supply chain security/continuity.
- Works collaboratively with Pharmaceutical Sciences, 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 execution to support launches into new markets
- Other duties as assigned.
EXPERIENCE & QUALIFICATIONS:
- Bachelor’s degree in a science, engineering or related discipline, Masters preferred.
- Very strong analytical, organizational, interpersonal, and communication skills.
- Minimum 10 years’ experience (or an equivalent combination of education and experience) of experience in positions related to supply chain, project management, and partner relationships.
- 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 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-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.
- 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.
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.