Director of Analytical Services

The posting, as Harrow, Inc. wrote it

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 provider of ophthalmic disease management solutions in North America. 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 Retina Portfolio including IHEEZO ® , TRIESENCE ® , BYOOVIZ TM , and OPUVIZ TM
• A broad Dry Eye Disease product line , led by VEVYE ® and bolstered by well-known adjacent ocular surface disease products such as FLAREX ® and FRESHKOTE ®
• A peri-operative Surgical product line , led by TRIESENCE ® , and BYQLOVI TM
• A Rare and Specialty product line , which includes various high-need and utility products such as ILEVRO ® , NATACYN ® , and VERKAZIA ®
• A robust internal development pipeline with multiple late-stage candidates, including MELT-300, MELT-210, H-N08, and CR-01

Job Summary

The Director, Analytical Services is a hands-on leader who runs the analytical laboratory and works at the bench alongside the team. The role is accountable for the quality, compliance, and timeliness of all analytical testing that supports drug product release, stability, and qualification of raw materials and APIs. The Director personally performs complex testing, method development and validation, instrument troubleshooting, data review, and laboratory investigations, while setting the laboratory's scientific and operational direction. The Director partners closely with Quality and Operations to align laboratory capacity with production demand, serves as the analytical subject matter expert during regulatory inspections and audits, and drives the laboratory's modernization, including equipment renewal, LIMS, and
[…]
ons, chemical hygiene, and established safety procedures.

• Perform other duties and responsibilities as assigned.

Qualifications & Requirements

• Minimum BS in Chemistry, Pharmaceutical Sciences, or a related scientific discipline; MS or PhD preferred
• At least twelve years of analytical laboratory experience in a cGMP pharmaceutical environment, including at least five years in a laboratory leadership role with direct reports
• Current, hands-on bench expertise with HPLC, UPLC, GC, FTIR, UV-Vis, Karl Fischer, and related techniques, including instrument troubleshooting, and with chromatography data systems such as Chromeleon or Empower
• Willingness and ability to work at the bench as a player-coach, performing testing, method work, and data review alongside the team
• Demonstrated hands-on experience with analytical method development and validation, impurity testing, and stability programs
• In-depth knowledge of USP-NF, ICH guidelines, 21 CFR Parts 210, 211, and 11, and FDA expectations for data integrity
• Proven track record of leading OOS, deviation, and CAPA investigations using root cause analysis tools
• Experience hosting or supporting FDA and other regulatory inspections
• Working knowledge of Quality Management Systems (e.g., Veeva) and LIMS; experience leading a LIMS or paperless laboratory implementation is preferred
• Experience managing laboratory budgets, capital equipment planning, and contract laboratory relationships
• Strong leadership, decision-making, and cross-functional collaboration skills
• Excellent written and verbal communication skills, including the ability to present data and recommendations to senior leadership
• Must be computer literate, with working knowledge of Microsoft Office (Word, Excel, PowerPoint)
• Must be able to maintain a safe working environment and follow safety procedures

Position Type

• On-Site

Travel

• Up to 15%, including travel between company sites and to contract laboratories and vendors