Senior Director of External Manufacturing & Supply Chain

Role Summary

This remote role leads supply chain functions for Harrow’s branded product portfolio, including management of external manufacturers (CDMOs), procurement, inventory planning and logistics to ensure a reliable supply of safe, high-quality drug products. It entails identifying, selecting, negotiating with, and managing CMC vendors, including external manufacturers and suppliers of APIs, excipients, packaging, labeling, shipment services, and GMP storage of API, Drug Product, and finished goods. The role collaborates with clinical and commercial teams to understand anticipated needs and maintains inventory at target levels.

Responsibilities

• Develop and implement strategic initiatives to optimize external manufacturing operations, aligning with company goals and objectives.
• Oversee the execution of CMC initiatives to advance Harrow’s branded product portfolio.
• Lead vendor selection, contract negotiations, and ongoing performance management.
• Lead relationships with external CDMO partners, ensuring alignment with quality standards, timelines, and cost objectives, including devising, refining, and communicating work plans in order to ensure that Harrow’s CROs/CDMO partners remain aligned with project and program priorities.
• Identify, qualify, and manage Contract Development and Manufacturing Organizations (CDMOs), packaging and labeling vendors, and logistics partners.
• Identify and mitigate risks associated with external manufacturing operations, proactively implementing solutions to ensure continuity of supply.
• Manage domestic and international logistics, including shipment of raw materials, intermediates, and finished products.
• Establish Key Performance Indicators (KPIs), perform ongoing vendor management, monitor vendor performance, and track relevant vendor KPIs.
• Manage formulation activities for product candidates and any branded product technical changes.
• Manage the budget for external manufacturing and supply chain activities, ensuring cost-effective operations while maintaining quality standards.
• Ensure alignment with CMO production schedules, including mitigation of bottlenecks and proactive resolution of supply disruptions.
• Develop and maintain integrated supply plans for branded products, ensuring alignment with commercial forecasts and launch timelines.
• Oversee inventory planning, safety stock levels, and supply continuity to meet customer demand.
• Directs sourcing and supplying of raw materials, utilities, and outside services, as well as coordinating global commercial and clinical procurement efforts for branded products.
• Works with colleagues in CMC, QA, commercial, clinical, and regulatory affairs to ensure appropriate vendor selection and oversight.
• Proactively identifies, monitors, and addresses supply chain risks.
• Contributes to the drafting and/or review of relevant sections of Harrow’s regulatory filings.
• Develops and leads a culture of learning, respect, and employee growth; Establishes the department's strategic vision and mentors the supply team toward goal achievement.

Qualifications

• A bachelor’s degree in chemistry or equivalent is required; an M.S. in Biology, Chemistry, or a related field is preferred.
• At least 8 plus years of relevant and combined experience in supply chain management Manufacturing, Technical transfer, and CMC; with specific experience working with commercial-stage sterile pharmaceutical products.
• Strong understanding of current Good Manufacturing Practices (cGMP) principles, guidance documents, and regulations
• Strong background in managing CDMOs and GMP manufacturing partners.
• Strong organizational and leadership skills to coordinate evolving supply chain timelines and the ability to develop risk-based approaches for the rapid sourcing of materials and release of products.

Education

• Bachelor’s degree in chemistry or equivalent required; MS in Biology, Chemistry, or related field preferred.

Additional Requirements

• Remote
• Travel: Up to 40%