Sr. Director of External Manufacturing & Supply Chain

Before reading the job post, we encourage you to watch this video about our company. It gives you an inside look at how we started, the team and culture that made us successful, and where we're going. It's easy to read a job post and apply, but people often wonder about the culture and whether they would fit in. If you want to call Harrow your home and genuinely want to be part of a family and something big, then we encourage you to click this link and get to know us.

Who is Harrow?

Harrow (Nasdaq: HROW) is a leading North American ophthalmic-focused pharmaceutical company. Harrow is an incredible entrepreneurial company – where we celebrate the ability of every member of the Harrow Family to be the CEO of their job. Harrow’s values have driven interest over the past decade in attracting high-performing professionals in a variety of disciplines. Members of our Harrow Family often express their pride in being a part of our commitment to (1) innovation, (2) patient access to affordable medicines, and (3) our track record of having never turned down an ophthalmologist doing mission work around the world – providing free medicines in support of mission work aimed at giving or maintaining the gift of sight to those most in need.  We encourage you to learn more about Harrow and its unique culture to see if you’re the right person to help contribute as we build a truly exceptional company, one we are all so proud of!

Harrow’s ophthalmic pharmaceutical portfolio is one of the most comprehensive in the industry, including:

• An expanding Posterior Portfolio including IHEEZO^® and TRIESENCE^®
• A broad Dry Eye Disease product line, led by VEVYE^® and bolstered by well-known adjacent ocular surface disease products such as FLAREX^® and TOBRADEX^® ST
• A Specialty Anterior Segment product line, which includes various high-need and utility products such as ILEVRO^®, NEVANAC^®, and VERKAZIA^®

Job Summary

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.

Core 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.

Qualifications & 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.

Position Type

• Remote

Travel

• Up to 40%