Pathology Operations Leader - Toxicology Lab

ZP Group; Gaithersburg (MD); On-site; USD 92,000 - 130,000; Full time

Benefits offered by this job

Cigna Medical/Dental/Vision

401K

Sick Leave as Required by Law

Job summary

Piper Companies is seeking a Manager, Pathology Operations to lead the non-clinical toxicology laboratory in Gaithersburg, MD. You will supervise a team of clinical chemistry, hematology, coagulation and urinalysis staff, ensuring timely study support and strict GLP compliance.

You will manage QA/QC, SOPs, protocol reviews, instrument maintenance, and data integrity while collaborating with pathologists and study directors to deliver accurate pathology reports.

Qualifications

• 10+ years of medical laboratory experience.
• MT certification required; consideration for 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.

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.
• Support cross-functional initiatives and resource planning while maintaining quality and regulatory standards.

Job description

Piper Companies is seeking a Manager, Pathology Operations to lead the non-clinical toxicology laboratory in Gaithersburg, MD. You will supervise a team of clinical chemistry, hematology, coagulation and urinalysis staff, ensuring timely study support and strict GLP compliance.

You will manage QA/QC, SOPs, protocol reviews, instrument maintenance, and data integrity while collaborating with pathologists and study directors to deliver accurate pathology reports.