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Clinical Lab Supervisor, Oncology

External
billiontoone logoBilliontoone · Menlo Park, CA
Full-timeOn-siteToday
ComplianceDocumentationExcelLeadershipProcess ImprovementStatistical Analysis
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Responsibilities

  • General Supervision & Leadership
  • Serve as a designated CLIA General Supervisor for high-complexity testing in accordance with 42 CFR Part 493 and CAP accreditation standards
  • Provide day-to-day supervision of laboratory personnel, including CLSs and CLAs, during the pre-analytic, analytic, and post-analytic phases of testing
  • Act as the primary escalation point for technical, operational, and personnel issues during assigned shifts
  • Oversee staffing, scheduling, shift handoffs, and workload distribution to ensure operational continuity
  • Laboratory Operations & Testing
  • Perform and oversee high-complexity molecular oncology assays, supporting diagnostic testing for patient care
  • Ensure proper instrument operation, calibration, maintenance, and troubleshooting
  • Review, interpret, and verify test results and quality control data
  • Identify, investigate, and resolve deviations that may impact test performance or result integrity
  • Quality & Compliance
  • Ensure compliance with CLIA, CAP, state, and local regulatory requirements
  • Perform, review, and document quality control, corrective actions, and preventive maintenance
  • Participate in inspection readiness, audits, and regulatory responses
  • Lead or support SOP development, review, and biennial updates
  • Training & Continuous Improvement
  • Lead training, onboarding, and competency assessments for new and existing laboratory staff
  • Provide hands-on and theoretical training for new assays, processes, and instrumentation
  • Support process improvement initiatives, including assay validation, tech transfer, and troubleshooting
  • Partner cross-functionally with Quality, R&D, and Operations to drive continuous improvement

Requirements

  • Active California Clinical Laboratory Scientist (CLS) license (or CGMBS/generalist license) meeting CLIA requirements for high-complexity testing
  • Bachelor's degree in chemical, biological, physical, clinical laboratory science, or a related field
  • Minimum 4 years of clinical laboratory experience, including molecular and/or high-complexity testing
  • Meets CLIA General Supervisor qualifications under 42 CFR 493.1461, including appropriate education, training, and experience
  • Demonstrated hands-on experience with molecular biology techniques (e.g., DNA extraction, PCR, automated liquid handlers)
  • Strong working knowledge of LIMS, quality systems, and laboratory documentation
  • Proficiency with Google Docs, Excel, Word, and basic statistical analysis
  • Excellent attention to detail, organizational skills, and ability to perform under time-sensitive conditions
  • Strong written and verbal communication skills and a collaborative leadership style
  • Prior experience serving as a CLIA General Supervisor
  • Startup or high-growth laboratory experience
  • Background in medical genetics or oncology diagnostics
  • Experience working with cell-free DNA (cfDNA) or next-generation sequencing workflows
  • Benefits And Perks:
  • Working alongside brilliant, kind, passionate and dedicated colleagues, in an empowering environment, toward a global vision, striving for a future in which transformative molecular diagnostics can

Benefits

Health insuranceVision insurance

Additional Information

A Rare Opportunity to Shape the Future of Genomics Join a team of brilliant, passionate innovators determined to transform healthcare. At BillionToOne, we've built a category-defining, publicly traded company on Nasdaq where transparency fuels trust, collaboration drives breakthroughs, and every contribution moves the needle on our mission to make life-changing diagnostics accessible to all. We don't just aim for incremental improvements; we build products that are 10x better than anything that exists today. Our scientists, engineers, sales executives, and visionaries are united by an unwavering commitment to changing the standard of care in prenatal and cancer diagnostics. This is where cutting-edge science meets human compassion, and every innovation you contribute helps remove the fear of the unknown from some of life's most critical medical moments. If you're driven by purpose, energized by innovation, and ready to help shape the future of precision medicine at scale, this is where you belong. BillionToOne is seeking a Clinical Laboratory General Supervisor (GS) to support our Oncology product, Northstar, in a high-complexity CLIA laboratory environment. This role provides general supervision of personnel and daily laboratory operations, ensuring regulatory compliance, quality, and operational excellence across end-to-end cancer blood sample processing. This is a hands-on leadership role in a fast-growing, high-throughput molecular diagnostics lab. The General Supervisor will serve as a key operational leader and first point of escalation for CLS and CLA, partnering closely with the Technical Supervisor, Laboratory Director, and Quality team. This is an onsite position supporting the Monday-Friday Mid Shift (11:30 AM - 8:00 PM), with a planned transition to a PM shift (3:00 PM - 11:30 PM) later this year.


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