Supply Chain Manager

Supply Chain Manager Nura Bio South San Francisco, CA Job Details 11 hours ago Benefits Stock options Disability insurance Health insurance Dental insurance 401(k) Flexible spending account Vision insurance Qualifications Demand forecasting Full Job Description Nura Bio, Inc. (Nura Bio) is a clinical-stage biopharmaceutical company developing neuroprotective therapies for the treatment of a broad range of neurological diseases. Nura Bio's research and early development small molecule pipeline is focused on developing therapies that halt axon degeneration and/or modulate microglial responses to degeneration and injury, with the goal of conferring neuroprotection, across diseases of the central, peripheral, and ocular nervous system. We are seeking a Manager of Supply Chain to lead and oversee supply chain logistics and investigational drug for all clinical studies, in coordination with Clinical Operations, CMC, Regulatory, Quality, and Finance teams. The candidate must have a good understanding of drug development process and be able to independently forecast and manage supply and distribution needs for assigned clinical studies. This position will report to VP, CMC.

Key Responsibilities:

Demand planning and forecasting

• able to translate clinical study synopsis/protocols into actionable drug forecasts Supply strategies
• develop effective packaging and supply strategies maximizing available inventory by location and shelf life while minimizing waste Packaging
• oversee clinical packaging activities, coordinate release of drug for clinical use Inventory Management
• manage global depot inventory supporting clinical studies (Phase 1, 2 and/or 3) Label text
• develop and manage label text, coordinate translations and proofing processes Documentation
• review/approve vendor packaging, labeling, distribution batch records, protocols, and/or forms, as required Distribution and Logistics
• manage and monitor global distribution networks based on study requirements, including ensuring required Import/Export documentation is available Systems
• Implement and manage any required Interactive Response Technology (IRT) supply strategies, review and provide input on User Requirement Specifications (URS) and participate on User Acceptance Tests (UAT) as required Effective cross-functional collaborator and communicator.

Interface with CMC team, Regulatory Affairs, Quality Assurance, Clinical Operations groups, and others as required to meet project deliverables Financial acumen

• initiate proposals and purchase orders (POs), manage and approve invoices for CMC Vendors as required Vendor management
• effective vendor oversight ensuring timelines are met and manage external vendor relationships Procedures
• develop and establish Standard Operating Procedures (SOP's) as required Shipping Logistics
• able to address international import/ export, shipping incoterms, VAT, Tax & Duties queries Other activities as required could include managing global shipment and logistics coordination of Drug Substance, Drug Product and other compounds

Qualifications & Skills:

BS/BA degree in related disciplines and at least 5+ years of related experience, unless education and/or work experience exceeds minimum Clinical and/or commercial supply chain, planning or materials management, inventory management, and business process facilitation Experience with supplying global randomized, blinded studies Experience with managing/ approving POs and invoices Vendor management experience, specifically with Clinical Packaging and Distribution vendors Working knowledge of cGXP's, familiar with US, EU regulations applicable to investigational drugs and drug development process Strong organizational and project management skills, including ability to multitask and organize/track information. Demonstrated ability to work independently and with cross-functional teams, including Clinical Operations, CMC, Regulatory, Quality, and Finance teams. Customer Service oriented, collaborative and self-starter Proficient in Microsoft Outlook, Word & Excel. Excel modeling capabilities a plus Business travel may be required (