Clinical Laboratory Scientist

AccuScan Sciences; Milpitas (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

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.

This role requires hands-on experience with DNA extraction, NGS workflows, assay development, and regulatory compliance. The candidate will help build and optimize a high-throughput NGS operation and ensure data integrity.

Qualifications

• Active California CGMBS license.
• BS in Biochemistry, Molecular Biology or related field.
• 2+ years in molecular diagnostics or high-complexity CLIA labs.
• Experience establishing or scaling NGS-based clinical testing.
• Strong hands-on DNA extraction and high-throughput NGS experience.

Responsibilities

• Perform and oversee high-complexity molecular testing including DNA extraction and NGS workflows.
• Review and verify test results per SOPs and regulatory requirements.
• Ensure compliance with CLIA, CAP and California DoPH regulations.
• Support scaling and optimization of high-throughput NGS workflows.
• Lead assay improvements and platform transitions as required.
• Maintain inspection readiness and support CLIA/CAP audits.
• Oversee QC monitoring, deviation tracking and corrective actions.

Skills

Molecular diagnostics

NGS workflows

Assay development

Process optimization

Data integrity

Education

Bachelor's degree in Biochemistry or Molecular Biology

Tools

DNA extraction protocols

QC/QA systems

NGS platforms

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

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