Director, CLIA Laboratory at 10x Genomics

Pleasanton, California, United States -

Full Time

Start Date

Immediate

Expiry Date

23 Feb, 26

Salary

0.0

Posted On

25 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

CLIA Compliance, Laboratory Operations, Quality Management Systems, Accreditation Management, Regulatory Compliance, Assay Development, Clinical Bioinformatics, Laboratory Information Management Systems, Workflow Automation, Performance Verification, Continuous Improvement, Team Leadership, Training and Competency Assessment, Molecular Diagnostic Assays, Operational Excellence, Scientific Innovation, Communication

Industry

Biotechnology Research

Description

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. Collaborate closely with the Diagnostic Assay Development team and the Clinical Bioinformatics team to transition new single-cell and spatial assays into clinical use. Participate in defining and executing the broader 10x clinical diagnostics roadmap, ensuring the lab supports research, clinical validation, and early commercial activities. 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. Experience implementing and validating advanced molecular diagnostic assays, such as NGS, single-cell, or multiplexed spatial assays. 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.

Responsibilities

Lead the design, buildout, and commissioning of the CLIA laboratory, ensuring readiness for clinical operations. Oversee day-to-day operations, ensuring timely, accurate, and compliant testing of clinical samples.