Clinical Laboratory Scientist - Operations Development

About Sampling Human:Sampling Human is building an end to end single cell genomics pipeline that increases clinical measurement precision and unlocks new classes of tests. Our platform integrates important cell isolation, high throughput barcoding, and computation to remove the bottlenecks that have kept single cell genomics out of routine clinical use. We partner with leading diagnostics teams to build the precision measurement backbone for the next generation of tests. We are scaling laboratory operations quickly to support clinical trials, commercial programs, and assay transfer into CLIA partner labs across prenatal, minimal residual disease, and longevity.About this role:The Clinical Laboratory Scientist - Operations Development position is a foundational role in the development of our new clinical laboratory. This role will process patient samples through the clinical laboratory while maintaining high quality and compliance standards. In addition to processing patient samples, this role will be instrumental in: building out a new operations laboratory space, preparing for CLIA certification, operationalizing and scaling our single cell genomics pipeline as well as transferring our protocols to partner laboratories. This hands-on role will work cross functionally across several domains to take assays from “works in R&D” through workflow design, scaling, and validation to smooth and reliable operations. This role may require some travel. Responsibilities:Working with a cross-functional team and following all relevant regulations and procedures, the responsibilities of the Clinical Laboratory Scientist - Operations Development include: Laboratory Operations:Process patient samples following relevant SOPsSample accessioningSample data reviewQC reviewTroubleshoot laboratory issues as neededTrain new operatorsMentor and guide non licensed laboratory operatorsWrite, maintain, and follow SOPsRegular retrospective review of assay dataInstrument maintenanceFollow all procedures for document control, incident tracking, and quality assuranceCLIA/CAP certification preparation Audit preparationAssist with compliance, quality assurance, document control, and EH&S effortsOther responsibilities as assignedOperations Development and Technology Transfer:Transfer assays from R&D to OperationsTransfer protocols to partner laboratoriesWorkflow optimizationQC establishmentAssay characterizationIdentify improvement opportunitiesDesign and run assay improvement experimentsScale assay to meet sample volume needsLIMS set up and improvementRisk analysisDesign and run verifications and validationsCommunicate operations team needs to other departmentsParticipate in continuous improvement effortsOther responsibilities as assignedQualifications:Current Clinical Laboratory Scientist (CLS) or Clinical Genetics Molecular Biology Scientist (CGMBS) license issued by the state of CaliforniaBachelor’s degree in clinical lab science, biology, or physical scienceAt least 4 years of experience in a high complexity clinical laboratoryWorking knowledge of CLIA and CAP regulationsExperience in technology transfer, workflow design, cross functional projects, or assay launch within a clinical laboratory settingCLIA lab start up experience preferredExperience with Lean/5s or 6 sigma preferredFamiliarity with molecular biology techniquesAbility to pipette accuratelyGood verbal and written communication skillsCreativity, flexibility, and adaptabilityAttention to detailAbility to perform in a fast paced dynamic work environment