Manager, Supply Chain

Priovant Therapeutics is committed to developing therapies that address high unmet needs in autoimmune diseases. The Manager, Supply Chain will further this mission by managing global clinical supply programs. The successful candidate will directly manage packaging, labeling, and global distribution operations for our rare disease portfolio.

The Manager, Supply Chain reports to the Senior Director, Supply Chain. The position is fully remote, with periodic travel to meet with the team in the Durham, NC office is required.

Responsibilities

• Partner with Clinical Operations to identify clinical supply requirements and develop clinical supply plans for initial and subsequent packaging/labeling operations
• Participate in internal and external cross-functional team meetings
• Lead clinical supply meetings and develop dashboards for the clinical team
• Manage CMO operations including but not limited to: packaging, labeling, shipment, inventory management, global logistics, drug returns and destruction activities in accordance with Priovant's deliverables and timelines, request end of year cycle count
• Lead and coordinate global label creation and review/approvals including: country requirements review/approvals and label proof review/approvals
• Review/approve CMO batch records
• Author pharmacy manuals by Interpreting the intended protocol
• Manage IRT inventory stock levels and expiry dates at depots and clinical sites to bridge clinical supply requirements for forecasting and demand planning for all programs
• Monitor inventory levels at depots through the life of a trial to ensure supply and avoid stockouts
• Collaborate with CMC on production schedules to ensure timing of clinical drug product needs are met for all program deliverables
• Lead IRT set-up and UAT
• Contribute to the development of systems and tools and the development of the clinical supply business process and SOPs
• Manage temperature excursion
  
  

Qualifications

• Bachelor's degree in a scientific or technical discipline, with a preference for an advanced degree or equivalent combination of education and experience
• 4 years' end to end clinical supply chain experience within Biotech and/or pharma industries
• Experience in CMO management, including labeling, packaging, and distribution in North America and Europe
• Experience with IRT system and implementation
• Knowledge of cGMPs and relevant FDA and EU regulations and agencies
• Ability to communicate effectively both orally and in writing, both internally and with external vendors and partners
• Strong analytical and organizational skills
• Ability to manage relationships with all functional areas and cross-functional team members to promote understanding, ownership, and support of the project and facilitate key interdependencies while keeping all stakeholders informed and up to date on project details
• Ability to negotiate and resolve conflicts
• Ability to multi-task and work in a fast paced and dynamic environment
• Microsoft proficient (Outlook, Excel, Word, PowerPoint, and Project) and must have strong excel (formulas) knowledge