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 SOPs
• Sample accessioning
• Sample data review
• QC review
• Troubleshoot laboratory issues as needed
• Train new operators
• Mentor and guide non licensed laboratory operators
• Write, maintain, and follow SOPs
• Regular retrospective review of assay data
• Instrument maintenance
• Follow all procedures for document control, incident tracking, and quality assurance
• CLIA/CAP certification preparation
• Audit preparation
• Assist with compliance, quality assurance, document control, and EH&S efforts
• Other responsibilities as assigned

Operations Development and Technology Transfer:

• Transfer assays from R&D to Operations
• Transfer protocols to partner laboratories
• Workflow optimization
• QC establishment
• Assay characterization
• Identify improvement opportunities
• Design and run assay improvement experiments
• Scale assay to meet sample volume needs
• LIMS set up and improvement
• Risk analysis
• Design and run verifications and validations
• Communicate operations team needs to other departments
• Participate in continuous improvement efforts
• Other responsibilities as assigned

Qualifications:

• Current Clinical Laboratory Scientist (CLS) or Clinical Genetics Molecular Biology Scientist (CGMBS) license issued by the state of California
• Bachelor’s degree in clinical lab science, biology, or physical science
• At least 4 years of experience in a high complexity clinical laboratory
• Working knowledge of CLIA and CAP regulations
• Experience in technology transfer, workflow design, cross functional projects, or assay launch within a clinical laboratory setting
• CLIA lab start up experience preferred
• Experience with Lean/5s or 6 sigma preferred
• Familiarity with molecular biology techniques
• Ability to pipette accurately
• Good verbal and written communication skills
• Creativity, flexibility, and adaptability
• Attention to detail
• Ability to perform in a fast paced dynamic work environment