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Job Description
Analytical Laboratory Manager Position Summary We are seeking an experienced Analytical Laboratory Manager to build, establish, lead, and manage our analytical testing laboratory supporting an FDA-registered 503B Outsourcing Facility. This individual will serve as the technical leader for potency testing, method development, method validation, stability testing, and laboratory compliance activities while ensuring adherence to FDA regulations, cGMP requirements, and data integrity standards. The successful candidate will play a critical role in building laboratory capabilities, supporting product release testing, maintaining inspection readiness, and developing a scalable analytical program to support continued growth. This is a hands-on leadership position responsible for both laboratory management and execution of analytical testing activities. Essential Responsibilities Laboratory Leadership & Management Establish and manage day-to-day operations of the analytical laboratory. Develop laboratory systems, workflows, and testing strategies. Recruit, train, mentor, and supervise laboratory personnel. Manage laboratory schedules, resources, and testing priorities. Develop departmental goals, metrics, and continuous improvement initiatives. Ensure laboratory operations meet FDA, USP, and cGMP requirements. Support future laboratory expansion and additional instrumentation. Analytical Testing Perform and oversee potency testing of pharmaceutical products using HPLC and related analytical techniques. Analyze raw materials, in-process samples, finished products, and stability samples. Review and approve analytical results. Ensure accurate and timely product release testing. Evaluate chromatographic data and investigate atypical results. Method Development & Validation Develop analytical methods for new compounded pharmaceutical products. Design and execute method development studies. Author validation protocols and reports. Perform method validation in accordance with:
ICH Q2 USP
requirements FDA expectations Transfer validated methods between laboratories when necessary. Establish product specifications and acceptance criteria. Stability Program Management Design and support stability studies. Develop stability-indicating analytical methods. Monitor stability samples and testing schedules. Analyze stability data and generate reports. Support product expiration dating programs. Instrumentation & Laboratory Systems Operate and maintain laboratory instrumentation including:
HPLC/UPLC
UV-Visible Spectrophotometers FTIR Analytical Balances pH Meters Osmometers Coordinate instrument calibration, qualification, and preventive maintenance. Troubleshoot instrumentation issues and coordinate vendor support. Support instrument
IQ/OQ/PQ
activities. Quality Systems & Compliance Ensure compliance with: 21 CFR Parts 210 and 211 cGMP regulations Good Laboratory Practices (GLP) USP standards Internal SOPs and Quality Systems Maintain GMP-compliant laboratory documentation. Review and approve laboratory records and test results. Support internal audits and quality improvement initiatives. Data Integrity Ensure compliance with FDA Data Integrity requirements. Review chromatographic audit trails. Maintain ALCOA+ data integrity principles. Ensure electronic records and laboratory software systems remain compliant. Support implementation and management of laboratory information systems. Investigations & CAPA Lead investigations involving: Out-of-Specification (OOS) Results Out-of-Trend (OOT) Results Laboratory Deviations Instrument Failures Conduct root cause analyses. Develop corrective and preventive actions (CAPAs). Verify CAPA effectiveness and closure. Regulatory & FDA Inspection Support Serve as Subject Matter Expert (SME) for analytical laboratory operations during FDA inspections. Present analytical methods, validation packages, and laboratory controls to regulatory inspectors. Support responses to FDA observations and audit findings. Maintain inspection readiness at all times. Collaborate with Quality Assurance and Regulatory Affairs teams. Required Qualifications Education Bachelor's Degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related scientific discipline. Master's Degree preferred. Experience Minimum 8 years of pharmaceutical analytical laboratory experience. Minimum 3 years in a leadership or supervisory role. Experience supporting FDA-regulated pharmaceutical manufacturing environments. Experience in sterile pharmaceutical manufacturing or 503B outsourcing facilities strongly preferred. Extensive experience with HPLC method development and validation. Required Technical Skills
HPLC/UPLC
operation and troubleshooting Method Development Method Validation Stability Testing Chromatographic Data Analysis Statistical Analysis Root Cause Investigations FDA cGMP Compliance Data Integrity Programs SOP Development Technical Report Writing Preferred Experience FDA inspection experience 503B Outsourcing Facility experience USP <71>, <85>, <788>, <797>, and <800> familiarity Stability-indicating method development Empower, OpenLab, or equivalent chromatography software Instrument qualification (IQ/OQ/PQ) Laboratory startup and buildout experience Compensation & Benefits Competitive salary based on experience Annual performance bonus Relocation assistance H-1B transfer sponsorship available Medical, dental, and vision insurance Paid time off and company holidays Professional development opportunities Why Join Us? This is a unique opportunity to build and lead an analytical laboratory within a growing FDA-registered 503B outsourcing facility. The successful candidate will have significant influence over laboratory strategy, instrumentation selection, method development programs, and future team growth while contributing directly to patient safety and product quality.
Pay:
$60,000.00 - $95,000.00 per year
Benefits:
Dental insurance Health insurance Life insurance Paid time off Relocation assistance Vision insurance
