Manager, Pathology Operations

Piper Companies is looking for a Manager, Pathology Operations to join a non-clinical toxicology laboratory organization located in Gaithersburg, MD
.

• 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

• 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 DXC
  500AU
  chemistry analyzers
• Hands‑on experience with Sysmex Clinitek Novus urinalysis systems

• Salary Range: $92,000 - $130,000+ annually, depending on experience
• Comprehensive Benefit Package:
  Cigna Medical/Dental/Vision, 401K, Sick Leave as Required by Law