GLP Pathology Operations Manager

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

Benefits offered by this job

Health benefits

401(k)

Job summary

Piper Companies is seeking a Manager, Pathology Operations to lead a non-clinical toxicology laboratory in Gaithersburg, MD. You will oversee daily operations, supervise staff across chemistry, hematology, coagulation, urinalysis, and urine chemistry testing, and ensure timely study support.

You will partner with pathologists, manage QC, review protocols, and drive optimization of processes to meet GLP standards. Strong leadership and communication are essential for success in this on-site role.

Qualifications

• 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 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

Strong communication skills

Team supervision

Process improvement

Microsoft Office proficiency

Education

MT certification

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 operations, supervise staff across chemistry, hematology, coagulation, urinalysis, and urine chemistry testing, and ensure timely study support.

You will partner with pathologists, manage QC, review protocols, and drive optimization of processes to meet GLP standards. Strong leadership and communication are essential for success in this on-site role.