What are the responsibilities and job description for the Manager, Pathology Operations position at Piper Companies?
Piper Companies is looking for a Manager, Pathology Operations to join a non-clinical toxicology laboratory organization located in Gaithersburg, MD.
Responsibilities of the Manager, Pathology Operations include:
Keywords: Clinical Pathology, Pathology Operations, Laboratory Management, Clinical Laboratory Management, Medical Technologist, MT Certification, MLT, MLS, ASCP, Non-Clinical Toxicology, Toxicology Studies, GLP, Good Laboratory Practices, FDA Regulations, Quality Control, Quality Assurance, QC Program Management, CAPA, SOP Development, SOP Compliance, Method Validation, Equipment Validation, Laboratory Operations, Personnel Management, Staff Supervision, Employee Development, Performance Management, Clinical Chemistry, Hematology, Coagulation, Urinalysis, Urine Chemistry, Blood Smear Review, Reticulocyte Analysis, Urine Microscopy, Laboratory Instrumentation, Laboratory Compliance, Data Review, Data Integrity, Report Review, Laboratory Documentation, Electronic Data Capture, Process Improvement, Change Management, Root Cause Analysis, Laboratory Workflow Optimization, Study Director Support, Cross-Functional Collaboration, Siemens Advia 2120i, ACL Elite Pro, Beckman Coulter DXC500AU, Sysmex Clinitek Novus, Regulated Environment, Life Sciences, Biotechnology, Pharmaceutical Research, Preclinical Research, Toxicology Testing, Laboratory Quality Systems, Laboratory Leadership, Laboratory Operations Management
Responsibilities of the Manager, Pathology Operations include:
- 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
- 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
- Salary Range: $92,000 - $130,000 annually, depending on experience
- Comprehensive Benefit Package: Cigna Medical/Dental/Vision, 401K, Sick Leave as Required by Law
Keywords: Clinical Pathology, Pathology Operations, Laboratory Management, Clinical Laboratory Management, Medical Technologist, MT Certification, MLT, MLS, ASCP, Non-Clinical Toxicology, Toxicology Studies, GLP, Good Laboratory Practices, FDA Regulations, Quality Control, Quality Assurance, QC Program Management, CAPA, SOP Development, SOP Compliance, Method Validation, Equipment Validation, Laboratory Operations, Personnel Management, Staff Supervision, Employee Development, Performance Management, Clinical Chemistry, Hematology, Coagulation, Urinalysis, Urine Chemistry, Blood Smear Review, Reticulocyte Analysis, Urine Microscopy, Laboratory Instrumentation, Laboratory Compliance, Data Review, Data Integrity, Report Review, Laboratory Documentation, Electronic Data Capture, Process Improvement, Change Management, Root Cause Analysis, Laboratory Workflow Optimization, Study Director Support, Cross-Functional Collaboration, Siemens Advia 2120i, ACL Elite Pro, Beckman Coulter DXC500AU, Sysmex Clinitek Novus, Regulated Environment, Life Sciences, Biotechnology, Pharmaceutical Research, Preclinical Research, Toxicology Testing, Laboratory Quality Systems, Laboratory Leadership, Laboratory Operations Management
Salary : $92,000 - $130,000