Clinical Laboratory Scientist, (General Supervisor)

Clinical Laboratory Scientist, (General Supervisor)

Pleasanton, California, USA HQ

About The Role: 10x Genomics is establishing a diagnostics effort to translate our leading single-cell and spatial genomics technologies into impactful clinical applications. This Clinical Laboratory Scientist/General Supervisor position performs and provides scientific and technical oversight for high complexity next-generation sequencing (NGS) assays within a CLIA-certified laboratory. This role is accountable for ensuring the operational execution, analytical validity, performance, and regulatory compliance of all NGS testing. The Technical Supervisor serves as the subject matter expert for assay validation, quality systems, and troubleshooting, and partners closely with laboratory leadership to maintain operational excellence and continuous improvement.

What You Will Be Doing:

• Provide operational execution and technical oversight of high complexity NGS assays, ensuring analytical accuracy and reliability of test results.
• Validate, and implement NGS assays in accordance with CLIA, CAP, and applicable regulatory standards.
• Establish and monitor quality control (QC) and quality assurance (QA) programs, including review of performance metrics, trends, and corrective actions.
• Author, review, and approve technical documentation, including standard operating procedures (SOPs), validation protocols/reports, and test methods.
• Ensure compliance with all regulatory requirements and support internal and external audits and inspections.
• Serve as the primary technical resource for troubleshooting complex assay, instrumentation, and bioinformatics issues.
• Evaluate and approve changes to assays, workflows, instrumentation, and software, including revalidation as required.
• Oversee proficiency testing, method comparisons, and ongoing assay performance monitoring.
• Provide technical training and competency assessment for laboratory personnel.
• Collaborate with cross-functional teams (bioinformatics, R&D, quality, and operations) to support assay optimization and innovation.
• Stay current with emerging technologies, regulatory updates, and best practices in NGS and molecular diagnostics.

To Be Successful in this Role, You Will Need:

• Active California Clinical Laboratory Scientist (CLS) license meeting CLIA requirements for Technical Supervisor of high complexity testing.
• Meets CLIA Technical Supervisor qualifications under 42 CFR 493.1449, including appropriate education, training, and experience
• Bachelor's degree in chemical, biological, physical, clinical laboratory science, or a related field.
• Minimum of 46 years of experience in CLIA lab molecular diagnostics, with significant experience in NGS assay validation, implementation, and operation
• Demonstrated expertise and experience in NGS technologies, including library preparation, sequencing platforms, and bioinformatics analysis pipelines
• Strong knowledge of CLIA, CAP, NYS, and other regulatory frameworks governing high complexity testing.
• Proven experience with assay validation, QC/QA systems, and regulatory inspections.

Additional attributes:

• Prior experience serving as CLIA Technical Supervisor
• Startup or high growth laboratory experience
• Background in medical or oncology diagnostics
• Excellent analytical, problem-solving, and decision-making skills.
• Strong written and verbal communication skills, with the ability to convey complex technical concepts clearly.