Director of Analytical Services

Harrow, Inc. • Nashville, TN

10h • Onsite

About The Position

The Director, Analytical Services is a hands-on leader responsible for the analytical laboratory’s quality, compliance, timeliness, scientific direction, and operations. The role supports drug product release and stability testing, as well as qualification of raw materials and APIs. The Director works at the bench alongside the team, personally performing complex testing, method development and validation, instrument troubleshooting, data review, and laboratory investigations.

The Director partners with Quality, Operations, and Supply Chain to align laboratory staffing, capacity, and schedules with production demand and release timelines. The role leads stability studies, maintains data integrity, serves as the analytical subject matter expert during inspections and audits, manages equipment and laboratory budgets, and oversees contract testing laboratories. It also drives laboratory modernization, including LIMS, chromatography data systems, and paperless workflows, while developing and coaching a high-performing laboratory team.

Requirements

• Bachelor’s degree or higher in Chemistry, Pharmaceutical Sciences, or a related scientific discipline; a master’s or PhD is preferred.
• At least 12 years of analytical laboratory experience in a cGMP pharmaceutical environment.
• At least five years in a laboratory leadership role with direct reports.
• Current hands-on expertise with HPLC, UPLC, GC, FTIR, UV-Vis, Karl Fischer, and related techniques, including instrument troubleshooting.
• Experience 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.
• 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 data integrity expectations.
• 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.
• Strong leadership, decision-making, and cross-functional collaboration skills.
• Excellent written and verbal communication skills, including presenting data and recommendations to senior leadership.
• Computer literacy and working knowledge of Microsoft Office (Word, Excel, and PowerPoint).
• Ability to maintain a safe working environment and follow safety procedures.

Nice To Haves

• Master’s degree or PhD in Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
• Experience leading a LIMS or paperless laboratory implementation.
• Working knowledge of Quality Management Systems such as Veeva and LIMS.

Responsibilities

• Provide strategic and operational leadership for the analytical laboratory, setting goals, priorities, and KPIs.
• Perform and direct routine and non-routine in-process, finished product release, stability, raw material, and API testing in compliance with specifications, USP-NF monographs, procedures, and cGMP requirements.
• Partner with Operations, Supply Chain, and Quality to forecast testing demand and plan staffing, instrument capacity, and scheduling.
• Personally lead and perform analytical method development, transfer, verification, and validation, including impurity and degradation product methods.
• Lead the stability program, including protocol design, study execution, data trending, and support for beyond-use dating assignments.
• Ensure data integrity across paper and electronic systems; perform second-person data and audit trail reviews and oversee electronic system access controls.
• Troubleshoot HPLC, UPLC, GC, and other instruments, and resolve chromatographic, method, and instrument issues at the bench.
• Perform routine bench testing and data review as needed to meet release timelines and manage peaks in testing volume.
• Conduct laboratory investigations, including OOS, OOT, and laboratory deviations, and establish scientifically sound root causes and effective CAPA.
• Represent the laboratory during FDA and state board of pharmacy inspections, customer audits, and internal audits, and lead timely responses to observations.
• Manage equipment and instrument lifecycles, including qualification, calibration, preventive maintenance, and replacement capital planning.
• Drive laboratory modernization, including LIMS, chromatography data systems, and paperless workflows, in partnership with IT and Quality.
• Develop and manage laboratory operating and capital budgets, and oversee contract testing laboratories, including qualification, technical oversight, and outsourced data review.
• Recruit, develop, and retain laboratory staff; set expectations, conduct performance reviews, and train and coach analysts at the bench.
• Author, review, and approve SOPs, specifications, test methods, protocols, and reports, and improve laboratory efficiency, quality, and compliance.
• Hold operational reviews with laboratory staff and senior leadership to communicate 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director