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10x Genomics · 1 week ago

Director, CLIA Laboratory

Pleasanton, CA

Full-time

Onsite

Director/Executive

$231K/yr - $313K/yr

10+ years exp

10x Genomics is dedicated to advancing biology and enabling scientists to tackle complex research questions. The Director of the CLIA Laboratory will establish and lead the company's first CLIA-certified laboratory, focusing on implementing and running innovative diagnostic assays while ensuring compliance and operational excellence.

Biotechnology

H1B Sponsor Likely

Responsibilities

Lead the design, buildout, and commissioning of the 10x CLIA laboratory, ensuring readiness for clinical operations

Develop, implement, and maintain CLIA-compliant standard operating procedures (SOPs), policies, and documentation systems covering all laboratory processes

Oversee the establishment of quality management systems aligned with CLIA and CAP

Prepare and manage all aspects of laboratory accreditation, including CAP inspections, CLIA certification, and New York State approval

Partner with regulatory and quality teams to ensure full compliance with applicable federal and state regulations

Oversee day-to-day operations of the CLIA laboratory, ensuring timely, accurate, and compliant testing of clinical samples and reporting of results

Implement laboratory information management systems (LIMS) and workflow automation to support scale and reproducibility

Manage assay onboarding from the Diagnostic Assay Development team, including technical transfer, performance verification, and documentation

Establish metrics for assay performance, turnaround time, and quality, ensuring continuous improvement

Lead and mentor a team of clinical laboratory scientists, supervisors, and technologists; provide training and competency assessments in accordance with CLIA and CAP requirements

Collaborate closely with the Diagnostic Assay Development team and the Clinical Bioinformatics team to transition new single-cell and spatial assays into clinical use

Partner with cross-functional teams in product development, quality assurance, and informatics to ensure readiness for clinical deployment

Serve as the laboratory’s primary point of contact for external audits, partner inspections, and internal reviews

Participate in defining and executing the broader 10x clinical diagnostics roadmap, ensuring the lab supports research, clinical validation, and early commercial activities

Qualification

CLIA-certified laboratory experienceMolecular diagnostic assaysLaboratory accreditation managementQuality management systemsLaboratory information management systemsTeam leadershipMentoringPhD in relevant fieldHigh-Complexity Laboratory Director certificationRegulatory compliance knowledgeCommunication skillsOrganizational skills

Required

PhD in molecular biology, clinical laboratory science, pathology, or related discipline

Board certification as a High-Complexity Laboratory Director (HCLD) under CLIA

Minimum 10 years' of experience in clinical laboratory operations, with 5 or more years in a leadership role overseeing CAP/CLIA-certified labs

Proven record of establishing or scaling clinical labs, including successful completion of CAP, CLIA, and New York State inspections

Experience implementing and validating advanced molecular diagnostic assays, such as NGS, single-cell, or multiplexed spatial assays

Deep understanding of quality systems, documentation control, and regulatory requirements for laboratory developed tests (LDTs)

Proficiency in the analysis, interpretation, and reporting of high-complexity clinical assays, including NGS- and image-based data analysis

Demonstrated ability to recruit, train, and lead laboratory staff in a high-complexity testing environment

Highly organized and methodical, with a focus on operational excellence and compliance

Thoughtful, hands-on leader with the ability to balance scientific innovation and regulatory discipline

Strong communicator, capable of engaging effectively with executives, regulators, and internal and external collaborators

Driven by building new capabilities and setting high standards for clinical quality and impact

Benefits

10x’s equity grants

Comprehensive health and retirement benefit programs

Annual bonus program or sales incentive program

Company

10x Genomics

Glassdoor3.5

Cells are the basic unit of life.

Founded in 2012

Pleasanton, California, US

1001-5000 employees

http://10xgenomics.com

H1B Sponsorship

10x Genomics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (41)

2024 (40)

2023 (35)

2022 (52)

2021 (34)

2020 (16)