Sr. Specialist, GMP Raw Material Supply Chain
Vir Biotechnology (Vir), a San Francisco company with a bold mission to end infectious disease, is seeking an experienced Supply Chain Specialist to oversee GMP raw material and critical reagent supply chain and compliance. The ideal candidate has a diverse background including supply chain management, vendor management, or quality control in the context of raw materials and critical reagents used for pharma/biologics manufacture.
- SOP implementation and maintenance for raw materials, critical reagents, starting materials, drug substance and drug product across multiple pipelines.
- Material procurement and inventory management across multiple company sites, CMOs, CTLs and academic partners.
- ERP/MRP system implementation.
- Demand forecasting for raw materials, critical reagents, drug substance and drug product.
- Supporting budgeting and cost of goods analysis.
- Raw material and critical reagent qualification: Project management, protocol authorship, testing lab management, data analysis and report authorship.
- Vendor management: Contracts, qualification, negotiation and relationship maintenance.
- Supporting Quality Assurance supplier qualification activities.
- The position will provide cross-functional support to quality control, analytical development, process analytics, clinical supply chain and other functions.
QUALIFICATIONS AND EXPERIENCE:
- 8+ years of experience in biotechnology or pharmaceutical supply chain, raw materials, quality control, project management or process development.
- Authorship of controlled GMP/GLP documentation including specifications, SOPs and test methods.
- Experience managing outsourced contract services and projects.
- Experience reviewing, negotiating and managing master service agreements, statements of work and other applicable contracts.
- Ability to quickly implement electronic systems or tracking tools to support project management (strategy, risk, demand).
- Ability to work under tight timelines and effectively communicate to internal stakeholders and external partners.
- Knowledge of raw material FDA regulations and USP/ICH guidelines.
- Diverse pipeline experience in antibody, siRNA, cell therapy, viral vector and/or small molecule modalities.
- Experience operating in early stage clinical to commercial environments.
- Experience in GMP raw material qualification, release and stability testing.
B.S. degree in relevant scientific discipline.