Director of Supply Chain

Position Overview

We are looking for a seasoned Director of Supply Chain to oversee the comprehensive supply chain strategy and its execution in preparation for the commercial launch of a prescription medication. This pivotal role involves establishing and managing all supply chain facets essential to smoothly transition from clinical to commercial supply stages. Key duties include demand planning, sales and operations planning (S&OP), direct supervision of drug manufacturing, packaging, labeling procedures, third-party manufacturing and distribution preparations, as well as management of contract manufacturing organizations (CMOs), contract packaging organizations (CPOs), and third-party logistics providers (3PLs). The role also encompasses product release planning and launch inventory control.

Key Responsibilities

• Formulate and implement a robust end-to-end commercial supply chain and launch readiness strategy covering manufacturing, packaging/labeling, distribution, and logistics to ensure an uninterrupted product supply.
• Lead demand forecasting, supply planning, inventory risk buffering, and scenario evaluation to inform decision-making.
• Define and monitor key supply chain performance indicators and dashboards to enhance performance and mitigate risks.
• Manage end-to-end manufacturing of drug products for commercial supply including planning, campaign preparation, execution, and continuous supply.
• Act as the main liaison with drug product CMOs, coordinating schedules, material flows, production yields, and release timelines; collaborate with Technical and Quality teams on handling deviations and product lot dispositions.
• Navigate supply risks, inventory considerations, cost factors, and timing challenges within a resource-constrained setting efficiently.
• Oversee commercial packaging and labeling activities, ensuring artwork, serialization readiness, and packaging execution meet requirements.
• Manage label lifecycle processes including version and change control and inventory management to fulfill regulatory and distribution demands while minimizing label obsolescence.
• Lead 3PL operations encompassing warehousing, order fulfillment, distribution, returns, and reconciliation; guarantee network readiness through standard operating procedures, service level agreements, and performance monitoring.
• Ensure compliance with Good Distribution Practice (GDP) and manage import/export activities to support reliable and compliant distribution.
• Drive the S&OP process by integrating inputs across Commercial, Finance, Quality, and Operations teams to align demand with supply and inventory levels.
• Develop and maintain demand forecasts as well as manage finished goods, work-in-progress (WIP), and packaging inventory to support both launch and ongoing supply, minimizing write-offs and obsolescence.
• Take charge of commercial change control, evaluating impacts related to supply, inventory, and distribution caused by Chemistry, Manufacturing, and Controls (CMC), labeling, site modifications, or process alterations.
• Collaborate with Technical, Quality, and Regulatory functions to implement post-approval changes and lifecycle plans — such as alternate manufacturing sites, process improvements, and scale adjustments — with minimal disruption to supply.
• Lead commercial lot release planning by coordinating testing, documentation, disposition, and distribution releases.
• Facilitate cross-functional release readiness evaluations, working closely with Quality and Regulatory to comply with Good Manufacturing Practice (GMP), GDP, serialization, and distribution requirements.
• Develop and maintain cost of goods sold (COGS) models alongside Finance and Technical teams; continually seek supply-driven cost efficiencies while preserving compliance and reliability.
• Conduct supply risk assessments and implement mitigation actions including safety stock and alternate sourcing.
• Drive the enhancement of supply chain systems such as enterprise resource planning (ERP), forecasting, inventory management, and their related standard operating procedures.

Qualifications

• Minimum of 10 years’ experience in pharmaceutical or biotech supply chain management, including at least 5 years in leadership positions.
• Proven, hands-on involvement supporting commercial launches of prescription drugs with operational responsibility for drug manufacturing, packaging, labeling, and distribution activities.
• In-depth knowledge of GMP and GDP requirements and FDA regulatory standards.
• Bachelor’s degree in supply chain management, engineering, life sciences, operations, or a related professional certification.
• Experience managing contract manufacturing organizations, contract packaging organizations, and third-party logistics providers within regulated environments.

Preferred Experience

• Background in small-to-mid sized biotech firms transitioning from clinical to commercial phases.
• Hands-on experience with ERP or supply chain software implementations such as NetSuite, SAP, or Oracle.
• Familiarity with serialization and track-and-trace systems.

Core Competencies

• Strong strategic thinker combined with excellent operational execution skills.
• Comfortable as a hands-on leader adept at multitasking and managing diverse responsibilities.
• Expertise in risk mitigation, scenario planning, and fostering cross-functional alignment.
• Clear and effective communication skills with robust stakeholder management capabilities.
• Ability to establish structure and discipline in a dynamically evolving organizational environment.