
Clinical Laboratory Scientist, Flow Cytometry
- Carlsbad, CA
- $73,500-136,500 per year
- Permanent
- Full-time
- Works in a GMP/GCP/GLP/CLIA regulated environment and is responsible for following all applicable regulations
- Execute and troubleshoot flow cytometry procedures and assays in support of clinical trial testing
- Provide day-to-day direct supervision of unlicensed (testing personnel) performing CLIA assays
- May authorize and review technical documents including, but not limited to assay work instructions
- Conduct pre-analytical, analytical and post-analytical processes, including review and reporting of test results associated with clinical trial specimens
- Monitor test analyses and specimen examinations to ensure that acceptable levels of analytical performance are maintained
- Perform maintenance and functional tests of complex instruments
- Work directly with external vendors to resolve QC and equipment issues
- Identify problems that may adversely affect test performance or reporting of test results and immediately notify the technical supervisor or Laboratory Medical Director and Quality
- Ensure quality control testing is performed and is within acceptable limits
- Ensure that patient test results are not reported until all corrective actions, if needed have been taken and the test system is properly functioning
- Train personnel in technical and operational procedures and sign training records
- Evaluate and document the competency assessment of assigned testing personnel
- Review and sign-off equipment calibration, daily or monthly QC records, assay QC record
- Using critical thinking skills, analyze data for trends making recommendations to more senior scientific staff
- Ensuring that Quality Events such as incidents and deviations are proper documented, and for supporting/owning the immediate remediation and preventative actions
- Ensuring change requests are properly initiated, completed, and approved prior to the use of the assay, system, instrument, software, etc. being changed
- Maintaining up-to-date training records and ensuring training is complete prior to performing specific job functions
- Following approved and effective procedures to perform specific job functions, and ensuring procedures accurately reflect activities being performed
- BS/BA with scientific emphasis
- Current Clinical Laboratory Scientist license issued by the State of California
- At least 2-3 years relevant clinical laboratory experience (for BS/BA/MS), 0 years (for PhD)
- Demonstrated understanding of, and ability to apply principles, concepts, practices and standards associated with analytical assay development/validation and/or sample testing in a laboratory setting
- Demonstrated experience and understanding of techniques directly applicable to the services provided by Navigate BioPharma (tissue culture, molecular and cellular biological techniques such as PCR, flow cytometry, IHC, etc.) is strongly preferred
- Excellent written and oral communication and intrapersonal skills required
- Demonstrated critical thinking skills
- Ability to operate independently
- English