Clinical Laboratory Scientist

AccuraGen; Milpitas (CA); On-site; USD 90,000 - 140,000; Full time

Job summary

AccuScan Sciences in California seeks a California-licensed Clinical Genetic Molecular Biologist Scientist (CGMBS) to support high-complexity molecular diagnostic testing in a CLIA-certified lab. This role emphasizes NGS workflows, assay development, and regulated clinical operations.

You will lead high-throughput molecular testing, lab build-out, and process improvements to scale testing while ensuring compliance with CLIA, CAP, and state regulations.

Qualifications

• Active California CGMBS license.
• Bachelor's degree in Biochemistry, Molecular Biology, or related field.
• 2+ years in molecular diagnostics or high-complexity CLIA laboratories.
• Experience establishing or scaling NGS-based clinical testing.
• 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.

Responsibilities

• 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.
• 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.
• 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.

Skills

CGMBS License

DNA extraction

NGS workflows

Regulatory compliance

Process improvement

Laboratory operations

CLIA/CAP experience

Education

Bachelor's degree in Biochemistry or Molecular Biology

Job 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
• 2+ 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