Pathology Operations Manager – GLP Laboratory Leader

Zachary Piper Solutions; Gaithersburg (MD); On-site; USD 92,000 - 130,000; Full time

Benefits offered by this job

Cigna Medical/Dental/Vision

401K

Sick Leave

Job summary

Piper Companies is seeking a Manager, Pathology Operations to lead a non-clinical toxicology laboratory in Gaithersburg, MD. You will oversee daily lab operations, supervise a team of medical technologists, and ensure GLP-compliant data handling and reporting.

The role emphasizes process improvement, staff development, and collaboration with pathologists to validate methods and prepare clinical pathology reports.

Qualifications

• 10+ years of medical laboratory experience.
• MT certification required; candidates actively pursuing certification may be considered.
• Experience supervising laboratory personnel and training staff.
• Experience with GLP and regulated laboratory environments.
• Strong oral and written communication skills.
• Proficiency with Microsoft Office applications.

Responsibilities

• 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.

Skills

medical laboratory experience

MT certification

Supervising laboratory personnel

Process improvement

GLP compliance

Communication skills

Microsoft Office

Education

Bachelor's degree preferred

Tools

Siemens Advia 2120i hematology analyzers

ACL Elite Pro coagulation instrumentation

Beckman Coulter DXC500AU chemistry analyzers

Sysmex Clinitek Novus urinalysis systems

Job description

Piper Companies is seeking a Manager, Pathology Operations to lead a non-clinical toxicology laboratory in Gaithersburg, MD. You will oversee daily lab operations, supervise a team of medical technologists, and ensure GLP-compliant data handling and reporting.

The role emphasizes process improvement, staff development, and collaboration with pathologists to validate methods and prepare clinical pathology reports.