Manager/Lead-Analytical Test and Validation

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

The Manager/Lead – Analytical Testing and Validation is responsible for overseeing analytical strategy, testing, and validation activities to support technology transfer of ophthalmic drug products at Contract Manufacturing Organizations (CMOs). This role ensures that analytical methods are developed, validated, and transferred in compliance with cGMP and regulatory requirements, while providing technical leadership across cross-functional teams. The individual will play a key role in ensuring robust analytical support for manufacturing, product quality, and successful commercialization.

Core Responsibilities

• Lead and manage analytical testing and validation activities to support technology transfer of ophthalmic products to CMOs.
• Oversee the review, approval, and execution of analytical method development, qualification, validation, and transfer protocols and reports.
• Act as the primary analytical subject matter expert (SME) during technology transfer, scale-up, and validation activities.
• Partner with CMOs, Quality Control, Quality Assurance, MS&T, and Regulatory Affairs to ensure alignment on analytical requirements and deliverables.
• Review and provide technical input on tech transfer packages, analytical data, and regulatory submission documents.
• Troubleshoot analytical issues and provide scientifically sound solutions to ensure compliance, accuracy, and reproducibility.
• Monitor progress of analytical deliverables across multiple projects, ensuring timelines and quality standards are met.
• Develop and implement best practices, procedures, and continuous improvement initiatives for analytical testing and validation.
• Provide mentorship and guidance to team members, fostering professional growth and technical excellence.
• Ensure adherence to global regulatory standards, ICH guidelines, and company quality policies.

Qualifications & Requirements

• Bachelor’s or Master’s degree in chemistry, Pharmaceutical Sciences, or related field (PhD preferred).
• 8+ years of experience in analytical development, validation, and tech transfer within the pharmaceutical or biotech industry.
• Strong knowledge of cGMP, ICH, FDA, and EMA guidelines related to analytical validation and regulatory submissions.
• Proven experience working with CMOs and leading analytical method transfers.
• Strong project management, leadership, and cross-functional collaboration skills.
• Excellent problem-solving, communication, and technical writing abilities.

Position Type

• Remote