Director of Analytical Service

Harrow; Nashville (TN); On-site; USD 180,000 - 240,000; Full time

Job summary

Harrow seeks a Director, Analytical Services to lead the analytical laboratory in North America. The role combines bench science with strategic oversight, ensuring timely drug product release, stability work, and raw material testing while aligning with Quality and Operations.

The successful candidate will drive modernization (LIMS, data systems), oversee audits/inspections, and manage a team of chemists and data reviewers, maintaining ALCOA+ data integrity and CAPA processes.

Qualifications

• Minimum BS in Chemistry, Pharmaceutical Sciences, or related scientific discipline; MS/PhD preferred.
• Hands-on bench experience with analytical techniques and data systems.
• Ability to lead a laboratory in cGMP environment and drive compliance.

Responsibilities

• Provide strategic and operational leadership for the analytical laboratory.
• Perform and direct routine and non-routine analytical testing in compliance with USP‑NF and cGMP.
• Forecast production testing demand and plan staffing, capacity, and scheduling.
• Lead method development, transfer, verification, and validation at the bench.
• Oversee QA/QC activities, data integrity, and regulatory inspections.
• Drive laboratory modernization including LIMS and paperless workflows.
• Recruit, develop, and manage a high-performing team of chemists and analysts.

Skills

Laboratory leadership

Bench testing

HPLC

Method development

Data review

Education

Bachelor's in Chemistry

Tools

Chromeleon

Empower

LIMS

MS Office

Job description

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:

• 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 BYQLOVITM
• 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 paperless data systems.

Core Responsibilities

• Provide strategic and operational leadership for the analytical laboratory, including setting laboratory goals, priorities, and key performance indicators (KPIs) such as on‑time release, right‑first‑time testing, data review cycle time, OOS and investigation closure rates, and equipment uptime.
• Perform and direct routine and non‑routine analytical testing, including in‑process, finished product release, stability, raw material, and active pharmaceutical ingredient (API) testing, in compliance with approved specifications, USP‑NF monographs, written procedures, and cGMP requirements (21 CFR Parts 210 and 211).
• Partner with Operations, Supply Chain, and Quality to forecast production volume and testing demand, and plan laboratory staffing, instrument capacity, and scheduling to meet release timelines.
• Personally lead and perform analytical method development, transfer, verification, and validation at the bench consistent with ICH Q2(R2), ICH Q14, and USP <1225>, <1226>, and <1224>, including impurity and degradation product methods.
• Lead the stability program, including protocol design, study execution, data trending, and support for beyond‑use dating (BUD) assignments.
• Ensure data integrity across paper and electronic systems in accordance with ALCOA+ principles and 21 CFR Part 11; perform second‑person data review and audit trail review and oversee electronic system access controls.
• Serve as the laboratory's primary technical troubleshooter for HPLC, UPLC, GC, and other instruments, and resolve chromatographic, method, and instrument issues directly at the bench.
• Step into routine bench testing and data review as needed to meet release timelines and cover peaks in testing volume.
• Own and personally conduct laboratory investigations, including OOS, OOT, and laboratory deviations, with timely, scientifically sound root cause analysis and effective CAPA within the Quality Management System (e.g., Veeva).
• Serve as the analytical subject matter expert and primary laboratory representative during FDA inspections, state board of pharmacy inspections, customer audits, and internal audits, and lead timely responses to observations.
• Lead equipment and instrument lifecycle management, including qualification (IQ/OQ/PQ), calibration, preventive maintenance, and capital planning for replacement of aging equipment.
• Drive laboratory modernization initiatives, including the implementation of LIMS, chromatography data systems (e.g., Chromeleon), and paperless laboratory workflows, in partnership with IT and Quality.
• Develop and manage the laboratory operating and capital budgets, and oversee contract testing laboratories, including vendor qualification, technical oversight, and review of outsourced data.
• Recruit, develop, and retain a high‑performing team of chemists, data reviewers, and laboratory managers; set clear expectations, conduct performance reviews, and train and coach analysts at the bench on techniques, methods, and good documentation practices.
• Author, review, and approve SOPs, specifications, test methods, protocols, and reports, and drive continuous improvement in laboratory efficiency, quality, and compliance.
• Hold regular operational reviews with laboratory staff and senior leadership to communicate laboratory performance, risks, and resource needs.
• Maintain a safe laboratory environment in compliance with OSHA regulations, 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