Supply Chain Manager

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 (

Nura Bio offers a comprehensive and generous benefits package, including medical, dental, and vision insurance, life and disability insurance, health savings and flexible spending accounts (including dependent care), a 401(k) plan, and highly attractive stock options.

Nura Bio is proud to be an equal opportunity employer and will consider all qualified applicants for employment.

To learn more about our mission and our science, visit us at www.nurabio.com. If you have the experience we are seeking and would like the opportunity to contribute to our mission, we would like to hear from you!