Manager, Clinical Pathology

BASI GAITHERSBURG LLC; Gaithersburg (MD); On-site; USD 78,370 - 105,130; Full time

Benefits offered by this job

Health and dental coverage

Short- and long-term disability

Paid time off

Paid parental leave

401(k)

Job summary

Inotiv in Gaithersburg, MD, is seeking a Manager, Clinical Pathology to lead multiple functional teams, oversee daily operations of the laboratory, and ensure timely completion of studies in a regulated setting.

The successful candidate will bring at least ten years of medical laboratory experience, MT certification, and a solid understanding of GLP and regulatory requirements, with responsibilities including performance reviews, QA/QC, and mentoring junior staff.

Qualifications

• At least 10 years medical laboratory experience.
• MT certification is required.
• Knowledge of GLP and regulatory agencies is desirable.

Responsibilities

• Directs workflow across multiple functional teams to meet study timelines.
• Plans, schedules and allocates resources to achieve department goals.
• Conducts annual performance evaluations of supervised personnel.
• Oversees laboratory QA/QC programs and records to ensure accuracy and reliability.
• Collaborates with pathologists to prepare clinical pathology data reports and validate equipment/methods.
• Maintains compliance with GLP and internal standards, and ensures proper documentation.
• Mentors junior staff and enforces universal safety procedures.

Education

MT certification

Job description

Job Title

Manager, Clinical Pathology

Qualifications

• At least 10 years medical laboratory experience.
• MT certification is required.
• Knowledge of Good Laboratory Practices (GLP) and regulatory agencies is desirable.

Corporate Responsibilities

• Adherence to laboratory health and safety.
• Adherence to Standard Operating Procedures (SOPs).
• Adherence to applicable company policies and guidelines.
• Adherence to federal and/or local regulations as applicable.

Position 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 contact 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 (e.g., 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 provides leadership and mentoring to junior staff members.
• Practices universal safety precautions when working with blood samples.
• May work with potentially hazardous substances.
• Wears required PPE (personal protective equipment).
• Performs other related duties as assigned.

Professional Responsibilities

• Attends continuing education courses, as appropriate.
• Maintains active involvement in professional medical/clinical laboratory organizations.

Pay

Estimated starting salary: $92,200 annually. Salary varies within the range based on factors including, but not limited to, prior relevant experience, skills, education, certification, location, as well as internal equity and market data.

Benefits

• Health and dental coverage
• Short- and long-term disability
• Paid time off
• Paid parental leave
• 401(k)
• More

Equal Employment Opportunity

Inotiv is an Equal Opportunity Employer. It is our policy to provide a fair and equal employment opportunity to all persons, regardless of age, race, color, religion, sex, gender, gender identity, gender expression, sexual orientation, genetic information, disability, national origin, veteran status, or any other basis prohibited by law. This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination and access to benefits and training. At Inotiv, our people are our greatest asset. We are committed to equality, opportunity, and diversity, and to treating our colleagues with the dignity and respect they deserve.