Director Of Analytical Services

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 , , and , 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