Responsibilities: of the Manager, Pathology Operations include: • Oversee daily operations of the clinical pathology laboratory supporting non-clinical toxicology studies • Supervise and develop a team of medical laboratory professionals performing clinical chemistry, hematology, coagulation, urinalysis, and urine chemistry testing • Schedule laboratory activities and delegate work assignments to ensure timely study support • Evaluate employee performance and support training and personnel development initiatives • Partner with pathologists to prepare clinical pathology reports and support equipment and method validation activities • Serve as the primary laboratory contact for Study Directors and in-life technicians regarding testing and sample-related issues • Manage the laboratory quality control program, including QC records, troubleshooting QC issues, and establishing control ranges • Review study protocols to ensure testing requirements can be supported and completed accurately • Oversee operation, maintenance, troubleshooting, and performance of laboratory analyzers and equipment • Perform and review manual testing procedures including blood smear reviews, reticulocyte evaluations, and urine microscopy when necessary • Prepare, review, and maintain laboratory SOPs and supporting documentation • Review and interpret laboratory data for acceptance, reporting, and compliance purposes • Maintain accurate records within laboratory data capture systems and ensure GLP compliance • Identify and implement process improvements that increase efficiency and reduce operational costs • Support cross-functional initiatives and resource planning while maintaining quality and regulatory standards Qualifications: for the Manager, Pathology Operations include: • 10+ years of medical laboratory experience • MT certification required; consideration may be given to candidates actively pursuing certification • Experience supervising laboratory personnel, training staff, and managing performance • Experience with process improvement and change management initiatives • Working knowledge of Good Laboratory Practices (GLP) and regulated laboratory environments • Strong oral and written communication skills • Proficiency with Microsoft Office applications • Bachelor's degree preferred Previous experience in a GLP-compliant laboratory preferred • Hands-on experience with Siemens Advia 2120i hematology analyzers • Hands-on experience with ACL Elite Pro coagulation instrumentation • Hands-on experience with Beckman Coulter DXC500AU chemistry analyzers • Hands-on experience with Sysmex Clinitek Novus urinalysis systems Compensation: for the Manager, Pathology Operations includes: • Salary Range: $92,000 - $130,000+ annually, depending on experience • Comprehensive Benefit Package: Cigna Medical/Dental/Vision, 401K, Sick Leave as Required by Law This job is open for applications on July 7th, 2026. Applications will be accepted at least 30 days from the posting date.
| Location | Gaithersburg, MD |
| Salary | $92,000–$130,000 Per Year |
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