Senior Specialist, Clinical Supply Chain
Vir Bio is seeking a Senior Clinical Supply Chain Specialist with experience in the pharmaceutical or biotech industry. You will manage supply chain oversight and logistics for technologies including siRNA, antibodies, viral vectors, and other cutting-edge pipelines. Responsibilities include e-system implementation and oversight (ERP/MRP/CTM), bill of material (BOM) maintenance, and contract management. Supply chain oversight will include clinical trial material, raw materials and critical quality control reference standards.
The ideal candidate will have a background specific to pharmaceutical or biotechnology products, and the unique supply chain challenges present in a GMP environment.
- Consolidate and maintain BOMs for multiple technologies.
- Build courier relationships for both domestic and international shipping capabilities that comply with FDA/EMA requirements.
- Manage outsourced GMP/GLP testing including contract approval, sample management, result tracking and billing.
- Author controlled documentation including standard operating procedures, policies and work instructions.
- Support raw material and critical reagent supplier identification and qualification.
- Manage cross site inventory tracking, production forecasts, and pre-qualification activities.
- Coordinate onboarding and ongoing management of GMP service providers.
- Supporting the Raw Material Management group via secondary sourcing projects, contract lab onboarding, validation study management, and general research to minimize raw material risk profiles.
QUALIFICATIONS AND EXPERIENCE:
- 5+ years of supply chain experience, preferably in the biotechnology or pharmaceutical field.
- Clinical trial material management including depot and courier setup, clinical trial portal interaction, material distribution and material return tracking.
- Experience in regulatory agency requirements pertaining to GMP materials.
- Experience implementing E-Systems for demand planning, inventory tracking, part number and vendor management.
- Experience shipping human derived materials globally.
- Experience managing outsourced contract services and projects.
- Ability to work under tight timelines and effectively communicate to internal stakeholders and external partners.
- Understanding of drug production CMC timeline elements that impact supply chain.
- B.S. in applicable scientific or business disciplines.