Director of Analytical Services

The role

The Director of Analytical Services is a hands-on leader who runs the analytical laboratory and works at the bench. This person is accountable for the quality, compliance, and timeliness of analytical testing for drug product release, stability, and qualification of raw materials and APIs.

What you will do

• Provide strategic and operational leadership for the analytical laboratory
• Perform and direct routine and non-routine analytical testing
• Partner with Operations, Supply Chain, and Quality to forecast production and testing demand
• Lead analytical method development, transfer, verification, and validation at the bench
• Lead the stability program including protocol design and study execution
• Ensure data integrity across paper and electronic systems
• Serve as the primary technical troubleshooter for HPLC, UPLC, GC, and other instruments
• Conduct laboratory investigations including OOS, OOT, and laboratory deviations
• Serve as the analytical subject matter expert during regulatory inspections and audits
• Lead equipment and instrument lifecycle management

Required qualifications

• Minimum BS in Chemistry, Pharmaceutical Sciences, or a related scientific discipline
• At least twelve years of analytical laboratory experience in a cGMP pharmaceutical environment
• At least five years in a laboratory leadership role with direct reports
• Hands-on bench expertise with HPLC, UPLC, GC, FTIR, UV-Vis, Karl Fischer, and related techniques
• Hands-on experience with chromatography data systems such as Chromeleon or Empower
• Willingness and ability to work at the bench as a player-coach
• 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
• Experience managing laboratory budgets, capital equipment planning, and contract laboratory relationships
• Computer literate with working knowledge of Microsoft Office (Word, Excel, PowerPoint)

Nice to have

• MS or PhD
• Working knowledge of Quality Management Systems (e.g., Veeva) and LIMS
• Experience leading a LIMS or paperless laboratory implementation

About the company

Harrow (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America. It is an entrepreneurial company with a commitment to innovation and patient access to affordable medicines.