Clinical Laboratory Scientist at AccuraGen

Description

AccuScan Sciences is seeking a California-licensed Clinical Genetic Molecular Biologist Scientist (CGMBS) to support and scale high-complexity molecular diagnostic testing within a CLIA-certified laboratory environment. This role is designed for an experienced molecular laboratory professional with demonstrated expertise in high-throughput next-generation sequencing (NGS), assay development, laboratory build-out, and regulated clinical operations.

Key Responsibilities

Clinical Operations & High-Complexity Testing

·       Perform and oversee high-complexity molecular testing including DNA extraction, sample preparation, and NGS workflows

·       Review and verify test results according to laboratory SOPs and regulatory requirements

·       Ensure compliance with CLIA, CAP, and California Department of Public Health regulations

Laboratory Build & Optimization

·       Support scaling and optimization of high-throughput NGS laboratory workflows

·       Contribute to laboratory build-out, workflow standardization, and documentation systems

·       Lead assay improvements and platform transitions when required

·       Implement process improvements to increase throughput, data quality, and operational efficiency

Quality & Regulatory Compliance

·       Maintain inspection readiness and support CLIA/CAP audits

·       Oversee QC monitoring, deviation tracking, and corrective actions

·       Participate in validation and verification of new assays and instrumentation

·       Ensure rigorous data integrity and standardized documentation practices

Requirements

Required Qualifications

·       Active California Clinical Genetic Molecular Biologist Scientist (CGMBS) License

·       B.S. in Biochemistry, Molecular Biology, or related field

·       5+ years of experience in molecular diagnostics or high-complexity CLIA laboratories

·       Demonstrated experience establishing or scaling NGS-based clinical testing

·       Strong hands-on experience with DNA extraction, sample preparation, and high-throughput NGS platforms

·       Deep understanding of CLIA/CAP regulatory standards

·       Proven ability to implement process improvements and optimize laboratory operations