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

Sampling Human

Open Positions at Sampling Human

Clinical Laboratory Scientist - Operations Development