Pathology Operations Manager - GLP Toxicology Lab

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

Benefits offered by this job

Medical, Dental, Vision coverage

401(k) plan

Sick leave as required by law

Job summary

Piper Companies is seeking a Manager, Pathology Operations to lead a non-clinical toxicology laboratory in Gaithersburg, MD. The role focuses on overseeing daily operations, supervising laboratory professionals, and ensuring timely study support with GLP compliance.

You will partner with pathologists to prepare clinical pathology reports, manage QC programs, and drive process improvements to increase efficiency and reduce costs while maintaining high quality standards.

Qualifications

• 10+ years of medical laboratory experience.
• MT certification required; consideration may be given to candidates actively pursuing certification
• Experience supervising laboratory personnel and managing performance
• Experience with process improvement and change management initiatives
• Working knowledge of GLP and regulated laboratory environments
• Strong oral and written communication skills
• Proficiency with Microsoft Office applications
• Bachelor's degree 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

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

Skills

Communication skills

Leadership

Education

Bachelor's degree preferred

Tools

Siemens Advia 2120i

ACL Elite Pro

Beckman Coulter DXC500AU

Sysmex Clinitek Novus

Job description

Piper Companies is seeking a Manager, Pathology Operations to lead a non-clinical toxicology laboratory in Gaithersburg, MD. The role focuses on overseeing daily operations, supervising laboratory professionals, and ensuring timely study support with GLP compliance.

You will partner with pathologists to prepare clinical pathology reports, manage QC programs, and drive process improvements to increase efficiency and reduce costs while maintaining high quality standards.