Akero Therapeutics

Supply Chain

• Lead clinical and commercial supply chain activities within Technical Operations and report to the Chief Technical Officer.
• Devise and facilitate the S&OP process; work with clinical and commercial teams to understand global product forecast, create simulations, and recommend capacity reservations.
• Ensure robust end-to-end supply chain of packaged and labeled commercial combination product with business continuity measures.
• Build and foster collaborative partnerships with CDMOs for manufacturing of clinical and commercial supplies and establish KPIs; suppliers include drug substance, product, device assembly and distribution to 3PL.
• Lead procurement and contract negotiations for agreements with all suppliers and storage facilities.
• Review or facilitate review of product specifications, change controls, master batch records, plans, protocols, reports, and deviations as needed.
• Manage logistics and inventory for warehousing, shipping, import/export including transport validation and temperature excursions.
• Support quality assurance for lot release of clinical and commercial batches and interface with QA to establish and maintain procedural documents.
• Author, review, and approve global health authority dossier sections for clinical trials and commercial licensure as required.
• Lead establishment and periodic review of business continuity plan; identify risks and contingency planning for mitigation.
• Ensure compliance with industry regulations and standards, including GMP and Good Distribution Practices.
• Monitor and control supply chain costs to optimize budget and improve profitability.

Vice President, Supply Chain