Manager, Pathology Operations

Inotiv•Gaithersburg, MD

4d•$92,200•Onsite

About The Position

The Manager, Pathology Operations is responsible for the effective operations of multiple functional teams within the laboratory. This role involves planning, scheduling, and organizing resources to meet study timelines and departmental goals. The Manager will also oversee annual performance evaluations, direct workflow, and collaborate with pathologists on data reports, equipment validation, and method validation. This position serves as the primary laboratory contact for communications with study directors and in-life technicians regarding sampling and testing issues. A key aspect of this role is managing the laboratory's quality control program, ensuring the accuracy and precision of analyzers, troubleshooting issues, and maintaining quality control records. The Manager will review study protocols to confirm laboratory capacity and ensure required tests are performed. Proficiency in operating and maintaining laboratory analyzers and equipment is essential, as is directing the maintenance of associated records. The role also includes performing manual testing, such as blood smears, reticulocyte smears, and urine microscopic examinations, when necessary. Conducting testing according to Good Laboratory Practices (GLP) and internal standards, maintaining compliance documentation, and preparing/updating Standard Operating Procedures (SOPs) are also core responsibilities. The Manager will review and interpret data, collect data using laboratory systems, and propose/implement process improvements for cost reduction and efficiency gains. This position requires independent work, leadership, mentoring of junior staff, and adherence to safety precautions, including the use of personal protective equipment (PPE) when working with potentially hazardous substances. Other related duties may be assigned.

Requirements

At least 10 years medical laboratory experience.
MT certification is required.

Nice To Haves

Knowledge of Good Laboratory Practices (GLP) and regulatory agencies is desirable.

Responsibilities

Responsible for the effective operations of a multiple functional teams.
Plans, schedules and organizes necessary resources to meet study timelines and departmental goals.
Responsible for annual performance evaluations of supervised personnel.
Directs workflow within the laboratory to ensure that adequate personnel are assigned to specific tasks.
Works closely with the pathologist to prepare clinical pathology data reports, and to validate equipment and methods.
Serves as the laboratory’s point of contract for communications with study directors and in-life technicians regarding sampling and testing problems.
Responsible for the laboratory’s quality control program.
Directs the maintenance of required quality control records to ensure the accuracy and precision of the analyzers, troubleshoots quality control issues, and establishes new ranges as necessary for new lots of quality control materials.
Reviews study protocols to ensure that the requested tests are within the capacity of the laboratory, and ensures that the required tests are performed.
Proficiency in the operation and maintenance of the laboratory’s analyzers and equipment.
Directs the maintenance of analyzer operational and maintenance records.
Performs manual testing of samples when necessary as an effective team member, such as preparation and review of blood smears, preparation and review of reticulocyte smears, and preparation and review of urine microscopic examinations.
Conducts testing in the clinical laboratory according to GLP and internal standards, and maintains the required documentation indicating compliance.
Prepares, reviews, and updates laboratory Standard Operating Procedures (SOP).
Reviews and interprets data for acceptance, and reporting purposes.
Collects data using the laboratory data capture systems, and maintains the required documentation indicating compliance.
Proposes and implements process improvements to reduce costs and increase efficiencies.
Performs duties independently and provide leadership and mentoring to junior staff members.
Practices universal safety precautions when working with blood samples.
May work with potentially hazardous substances.
Wears requires PPE (personal protective equipment).
Perform other related duties as assigned.