Sr. Director of External Manufacturing & Supply Chain

Harrow, Inc.

74d

About The Position

This position leads supply chain functions for Harrow’s branded product portfolio. This includes management of external manufacturers (CDMOs), procurement, inventory planning & management, and logistics to ensure a reliable supply of safe, high-quality drug products for Harrow’s branded portfolio of products. In collaboration with the relevant team members, this position is responsible for identifying, selecting, negotiating agreements with, and managing various CMC vendors including, but not limited to, external manufacturers and those providing raw materials (APIs, excipients, packaging), packaging, labeling, shipment services, GMP storage of API, Drug Product, and final finished goods. Working with clinical and commercial teams to understand anticipated needs, ensures the availability of drug products in the supply chain, as scheduled, and the maintenance of inventory at acceptable levels.

Requirements

• Bachelor’s degree in chemistry or equivalent is required; 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 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.

Responsibilities

• Develop and implement strategic initiatives to optimize external manufacturing operations, aligning with company goals and objectives.
• Oversee execution of CMC initiatives to advance Harrow’s branded product portfolio of products.
• 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, devise, refine, and communicate 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 selection and oversight of vendors.
• 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.

What This Job Offers

• Education Level: Bachelor's degree