Supply Chain Director

We are seeking an experienced Director of Supply Chain to lead end‑to‑end supply chain strategy and execution for a prescription drug, preparing for its first commercial launch. This role will be responsible for building and managing all supply chain capabilities required to transition from clinical to commercial supply, including demand planning, S&OP, direct oversight and execution of drug product manufacturing, packaging, and labeling operations, external manufacturing and distribution readiness, CMO/CPO/3PL management, product release planning, and launch inventory management. In this small biotech organization, the Director serves as the single‑threaded owner of finished drug product supply, from manufacturing through delivery to the market. The role requires both strategic leadership and hands‑on execution, working cross‑functionally with Technical, Quality, Regulatory, Finance, Commercial, and external partners to ensure launch readiness and ongoing commercial supply continuity. Key Responsibilities Launch Supply Chain Strategy & Launch Readiness Develop and execute the end-to-end commercial supply chain strategy and launch readiness plan (manufacturing, packaging/labeling, distribution, logistics) to ensure uninterrupted supply. Lead demand forecasting, supply planning, inventory strategy (risk buffers), and scenario modeling to support decisions. Define and track supply chain KPIs and dashboards to drive performance and proactively manage risk. Drug Product Manufacturing Management Own end-to-end drug product manufacturing for commercial supply (planning, campaign readiness, execution, and continuity). Serve as primary interface to drug product CMOs; align schedules, materials, yields, and release timing; partner with Technical and Quality on deviations and lot disposition. Manage tradeoffs across supply risk, inventory, cost, and timelines in a resource‑constrained environment. Packaging, Labeling & Commercial Product Presentation Lead commercial packaging and labeling operations end‑to‑end (CPOs, artwork readiness, serialization readiness, packaging execution). Manage label lifecycle (version control, change control, label inventory) to meet regulatory and distribution requirements and minimize obsolescence. Third‑Party Logistics & Commercial Distribution Lead 3PL operations (warehousing, order fulfillment, distribution, returns, reconciliation) and ensure network readiness via SOPs, SLAs, and KPI monitoring. Oversee GDP compliance and import/export activities to enable compliant, reliable distribution. Planning, S&OP & Inventory Management Build and run the S&OP process, integrating inputs from Commercial, Finance, Quality, and Operations to align demand, supply, and inventory. Develop demand forecasts; manage finished goods, WIP, and packaging inventory to support launch and ongoing supply while minimizing write‑offs and obsolescence. Commercial Supply Governance & Change Management Own commercial change control; assess supply, inventory, and distribution impacts of CMC, labeling, site, and process changes. Partner with Technical, Quality, and Regulatory to implement post‑approval changes and lifecycle plans (alternate sites, process improvements, scale changes) while minimizing supply disruption. Product Release, Compliance and Regulatory Interface Own commercial lot release planning; align testing, documentation, disposition, and distribution release. Lead cross‑functional release readiness reviews; partner with Quality and Regulatory to support GMP/GDP compliance, serialization, and distribution requirements. Cost of Goods & Systems Develop and maintain commercial COGS models with Finance/Technical; drive supply‑led cost improvements while maintaining compliance and reliability. Lead supply risk assessments and mitigation (safety stock, alternate sourcing); implement and improve supply chain systems (ERP, forecasting, inventory) and supporting SOPs. Qualifications Required 10+ years of experience in pharmaceutical or biotech supply chain, including at least 5 years in a leadership role. Direct, hands‑on experience supporting the commercial launch of a prescription drug, including operational ownership of drug product manufacturing, packaging/labeling, and distribution. Strong understanding of GMP/GDP requirements and FDA regulatory expectations. Bachelor’s degree in supply chain, engineering, life Sciences, operations, or equivalent professional certification. Experience managing CMOs, CPOs, and 3PLs in a regulated environment. Preferred Experience in small‑to‑mid‑size biotech companies transitioning from clinical to commercial stage. ERP or supply chain system implementation experience (e.g., NetSuite, SAP, Oracle). Serialization and track‑and‑trace experience. Strategic thinker with strong operational execution capability. Hands‑on leader comfortable wearing multiple hats. Skilled in risk management, scenario planning, and cross‑functional alignment. Clear, effective communicator with strong stakeholder‑management skills. Ability to build structure and discipline in an evolving organization. #J-18808-Ljbffr