IHC Laboratory Manager

<p><strong>Position Summary:</strong></p> <p>The Laboratory Manager is responsible for overseeing the daily operations of a high-complexity clinical and/or translational laboratory within a CAP/CLIA-regulated environment. This role ensures scientific excellence, regulatory compliance, and operational efficiency across Immunohistochemistry (IHC) and Fluorescence In Situ Hybridization (FISH) testing.</p> <p>In a Contract Research Organization (CRO) setting, the Laboratory Manager partners closely with cross-functional teams to support client-driven projects, clinical trials, and biomarker development efforts.</p> <p><strong>Essential functions of the job include but are not limited to:</strong></p> <ul> <li>Oversee IHC and FISH analyses, support assay development, and cross-train laboratory personnel on regulated IHC and FISH SOPs</li> <li>Manage testing personnel and ensure adherence to CAP/CLIA and GxP guidelines relevant to each assay/study</li> <li>Develop and manage staff schedules, including rotation and holiday coverage; serve as backup for laboratory testing as needed</li> <li>Ensure laboratory procedures are performed in accordance with SOPs by appropriately trained personnel; address deviations promptly and report issues to management and QA</li> <li>Ensure accurate sample tracking and testing documentation within LIMS</li> <li>Monitor and report KPIs, including turnaround time (TAT), quality event investigations and closures, staff capacity, and special project progress</li> <li>Maintain proficiency in laboratory operations by completing training on all relevant SOPs</li> <li>Oversee laboratory equipment and workspaces to ensure they are clean, well-maintained, and fully operational</li> <li>Recommend equipment replacement or maintenance based on performance and notify management/QA of any issues</li> <li>Monitor inventory of laboratory supplies, reagents, and consumables; order and replenish as needed</li> <li>Identify opportunities to improve efficiency and reduce laboratory supply costs</li> <li>Maintain competency across applicable assays and serve as backup testing personnel when necessary</li> <li>Drive efficient use of time, resources, and equipment</li> <li>Evaluate and improve laboratory procedures; provide recommendations to management</li> <li>Perform other duties as assigned</li> </ul> <p><strong>Qualifications:</strong></p> <p><strong><u>Minimum Required:</u></strong></p> <ul> <li>Bachelor’s degree in Biology, Chemistry, or a related scientific field</li> <li>8+ years of industry experience in a clinical, diagnostic, or CRO laboratory, including hands-on IHC assay experience</li&g