
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
Reasonable estimate of the current range
$110,700 - $166,100 USD
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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
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