Manager, Flow Cytometry (Clinical Laboratory Scientist)

Exagen is a patient-focused and discovery-driven life sciences company dedicated to transforming the care continuum for patients suffering from debilitating and chronic autoimmune diseases. Our goal is to enable rheumatologists to improve care for patients through the differential diagnosis, prognosis, and monitoring of complex autoimmune and autoimmune-related diseases, including lupus and rheumatoid arthritis. By leveraging our proprietary Cell-Bound Complement Activation Products, or CB-CAPs, technology, we help get to the real cause of a patient’s symptoms and guide their journey to improved health.

The Flow Cytometry Manager (Clinical Laboratory Scientist) has overall responsibility for the supervision of the flow cytometry laboratory's technical and operational activities to assure that flow cytometry tests are accurate, performed efficiently, and reported in a timely manner. The Flow Cytometry Manager will also work closely with the R&D department to implement new tests and identify opportunities for efficiency in the current workflow. The manager shall be accessible to the laboratory to provide on-site, telephone, or electronic consultation.

Responsibilities

Responsible for technical oversight of flow cytometry testing as delegated by the CLIA Laboratory Director.

Selection of the test methodology that is appropriate for the clinical use of the test results;

Verification of the test procedures performed and establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system;

Enrollment and participation in an HHS approved proficiency testing program commensurate with the services offered;

Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results;

Resolving technical problems and ensuring that remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications;

Ensuring that patient test results are not reported until all corrective actions have been taken and the test system is functioning properly;

Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed;

Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently

Work closely with the laboratory management and be an integral part of the laboratory leadership team.

May provide general supervisor’s duties by providing the day to day supervision of testing and non- testing personnel to meet quality, safety, and compliance regulations, maintain quality results by performing and or reviewing instrument comparison, alternate proficiency test, and other quality assurance requirements.

Evaluation workflows to achieve greater efficiencies and quality levels.

Directly responsible for ensuring the teams' adherence to protocols, appropriate management, and distribution of workload ensuring compliance with CLIA, CAP and NYDOH requirements.

Collaborate with R&D department for assay implementation and improvement.

Write, review, revise and approve policies, procedures and other associated documents.

Lead instrument and assay validation.

Participates in internal and external audits as required.

Other responsibilities include personnel recourse management by interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining direct reports; addressing complaints and resolving problems; providing coaching and constructive feedback and career development opportunities

Qualifications

Minimum Qualifications:

Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution and at least 2 years of laboratory training or experience, or both, in high complexity testing for Flow Cytometry, OR

Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution and have at least 4 years of laboratory training or experience, or both, in high complexity testing for Flow Cytometry

CA Clinical Laboratory Scientist (CLS) Generalist License

At least 2 years of direct supervision experience

Preferred Qualifications:

CAP/NYS inspection is a plus

ASCP or Equivalent Certification in assigned specialty

Salary range: $150,000 - $158,000

Regular Full-Time