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 Process Development Scientist position is a foundational role in the development of our new clinical laboratory bridging the gap between R&D and clinical laboratory operations. Working with CLS and R&D team members, this role will be instrumental in: operationalizing and scaling our single cell genomics pipeline, establishing QCs and KPIs, characterizing and robustifying the assays, as well as transferring our protocols to internal and external CLIA laboratories. This hands-on role will work cross functionally across several domains to take assays from “works in R&D” through assay characterization, workflow design, scaling, and validation to smooth and reliable operations. The position is expected to be very hands-on, spending the majority of time in the laboratory. This role will also process samples through our internal laboratory while maintaining high quality and compliance standards. Some travel may be required.
Responsibilities
Working with a cross-functional team and following all relevant regulations and procedures, the responsibilities of the Process Development Scientist include:
Process Development And Technology Transfer
- Transfer of assays from R&D to operations
- Assay and protocol optimization to increase reliability and reproducibility including potential changes to formulations or materials used
- Design and execution of assay characterization tests, verifications, and validations
- QC establishment
- Workflow optimization and scaling to meet sample volume needs
- Identification, characterization and establishment of KPIs (Key Performance Indicators)
- Communication of team needs to other departments
- Participation in continuous improvement efforts
- Participation in risk assessment activities
- SOP writing and editing
- Transfer of protocols to partner laboratories
- Other responsibilities as assigned
Laboratory Operations
- Sample processing following SOPs
- Assay troubleshooting
- Instrument maintenance
- Laboratory KPI monitoring and review
- New operator training
- Assistance with compliance, quality assurance, document control, and EH&S efforts
- Assistance with CLIA/CAP certification and audit preparation
- Other responsibilities as assigned
Qualifications
- BS, or higher in biological science, physical science, clinical lab science, or engineering
- 4 years of experience in technology transfer, process optimization, or assay development role supporting a high complexity CLIA laboratory
- Strong understanding of molecular and cell biology principles
- Experience in: QC establishment, assay validation design, KPI development, and related experimental design
- Expertise in workflow optimization and design
- Familiarity with data analysis, interpretation, and presentation
- Working knowledge of CLIA and CAP regulations
- Good verbal and written communication skills
- Creativity, flexibility, and adaptability
- Attention to detail
- Ability to perform in a fast paced dynamic work environment
- Preferred experience in: assay kit development, laboratory automation, and statistical process control
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