Circular Genomics · 1 day ago
Senior Scientist / Principal Scientist, Clinical Assay Development
San Diego, CA
Full-time
Hybrid
Senior Level, Lead/Staff
$130K/yr - $170K/yr
6+ years expCircular Genomics is a precision neuroscience diagnostics company leveraging proprietary circRNA biomarkers to transform the diagnosis and treatment of mental health and neurodegenerative disorders. They are seeking a Senior Scientist or Principal Scientist to lead hands-on execution of wet-lab assay development, validation, and clinical transfer for RNA-seq–based circRNA diagnostics.
BiotechnologyHealth CareNeuroscienceTherapeuticsWellness
Responsibilities
Perform hands-on laboratory work to develop, optimize, and standardize NGS and other molecular biology workflows, including sample preparation, library preparation, QC metrics, and sequencing performance for RUO and LDT assays
Characterize assay performance, identify sources of variability, and implement improvements to ensure reproducibility and robustness
Partner with bioinformatics to define and implement laboratory QC metrics and performance thresholds
Evaluate new technologies to enhance assay robustness and cost-effectiveness
Lead, execute and oversee analytical and clinical validation studies, compliant with CAP/CLIA, CLSI, and FDA guidelines
Own day-to-day study operations, data review, troubleshooting, and reporting
Support study design, analyze and summarize NGS data in collaboration with bioinformatics and biostatistics; prepare study results for internal reviews and cross-functional discussions
Lead and participate directly in assay transfer activities from R&D into the CLIA laboratory
Train and support Clinical Laboratory Scientists (CLS) during assay implementation and early clinical use
Mentor Research Associates through direct laboratory supervision and technical guidance
Support integration of laboratory workflows with the LIMS and bioinformatics pipelines
Ensure smooth end-to-end operations from sample accessioning and QC tracking through sequencing, analysis, and results reporting
Support inspection-ready workflows with clear audit trails and documented controls
Prepare wet-lab sections of validation reports, CAP/CLIA documentation, and technical summaries
Support FDA interactions in collaboration with senior leadership
Execute established change-control procedures and ensure compliance with 21 CFR Part 11, audit trails, and data integrity requirements
Author and maintain SOPs, work instructions, and method documentation
Partner closely with R&D, Bioinformatics, Operations, Clinical, Regulatory, and Quality teams to ensure assay and workflow readiness
Serve as a scientific subject-matter expert for assay execution within the organization
Qualification
Required
PhD or MS in Molecular Biology, Genomics, or related fields
6 - 9 years of industry experience in NGS assay development (RNA-seq, targeted and/or whole transcriptome approaches), molecular diagnostics, or regulated laboratory environments
Strong hands-on expertise with Illumina RNA-seq library preparation and NGS workflows
Experience executing analytical validation studies and supporting assay transfer into a clinical laboratory
Working knowledge of CAP/CLIA requirements, LDT development, and 21 CFR Part 11 expectations
Ability to analyze, interpret, and clearly communicate validation and performance data
Preferred
Experience supporting RUO and/or LDT assay development in a clinical diagnostics setting
Familiarity with circRNA biology, alternative splicing, or RNA-based biomarker assays
Background in neurology, neurodegeneration, or neuroscience-related biomarker development
Prior exposure to FDA submissions (e.g., Pre-Sub, 510(k), Breakthrough) in a supporting role
Experience in early-stage diagnostics companies or molecular technology startups
Company
Circular Genomics
Circular Genomics is a biotechnology and genomics company that develops RNA-based diagnostics for neurological diseases.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$28.07MKey Investors
Mountain Group CapitalAlzheimer's Drug Discovery FoundationNew Mexico Economic Development Department
2025-12-01Series A· $15M
2025-07-08Grant· $0.25M
2024-01-23Series A· $8.3M
Leadership Team
Nikolaos Mellios
Chief Scientific Officer
Recent News
Company data provided by crunchbase