IHC Laboratory Manager

Position Summary:

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.

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.

Essential functions of the job include but are not limited to:

• Oversee IHC and FISH analyses, support assay development, and cross-train laboratory personnel on regulated IHC and FISH SOPs
• Manage testing personnel and ensure adherence to CAP/CLIA and GxP guidelines relevant to each assay/study
• Develop and manage staff schedules, including rotation and holiday coverage; serve as backup for laboratory testing as needed
• Ensure laboratory procedures are performed in accordance with SOPs by appropriately trained personnel; address deviations promptly and report issues to management and QA
• Ensure accurate sample tracking and testing documentation within LIMS
• Monitor and report KPIs, including turnaround time (TAT), quality event investigations and closures, staff capacity, and special project progress
• Maintain proficiency in laboratory operations by completing training on all relevant SOPs
• Oversee laboratory equipment and workspaces to ensure they are clean, well-maintained, and fully operational
• Recommend equipment replacement or maintenance based on performance and notify management/QA of any issues
• Monitor inventory of laboratory supplies, reagents, and consumables; order and replenish as needed
• Identify opportunities to improve efficiency and reduce laboratory supply costs
• Maintain competency across applicable assays and serve as backup testing personnel when necessary
• Drive efficient use of time, resources, and equipment
• Evaluate and improve laboratory procedures; provide recommendations to management
• Perform other duties as assigned

Qualifications:

Minimum Required:

• Bachelor’s degree in Biology, Chemistry, or a related scientific field
• 8+ years of industry experience in a clinical, diagnostic, or CRO laboratory, including hands-on IHC assay experience
• 2+ years of leadership experience in a CAP- or CLIA-regulated laboratory
• ASCP certification (HT or equivalent)

Other Required:

• Strong organizational and time management skills
• Ability to work independently and make decisions with minimal supervision
• Experience operating analytical instruments commonly used in laboratory settings
• Proficiency in Microsoft Office (Word, Excel, PowerPoint)
• Strong communication and interpersonal skills, with the ability to directly supervise staff
• Demonstrated sound judgment and discretion
• Ability to read, write, and speak English fluently
• Willingness to work extended hours, including evenings, weekends, and holidays, and occasional travel as required to support business and scientific objectives

Preferred:

• Specialized knowledge in biochemistry, immunology, molecular biology, or cell biology