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BillionToOne, a publicly traded genomics and precision diagnostics company, is seeking a Clinical Laboratory General Supervisor to lead oncology laboratory operations for their Northstar product in a high-complexity CLIA laboratory environment. This is a hands-on management role supporting the PM shift (2:30 PM–11:00 PM, Monday–Friday) in Menlo Park.
You will serve as the designated CLIA General Supervisor and primary operational leader for the oncology lab, providing day-to-day supervision of Clinical Laboratory Scientists (CLS) and Clinical Laboratory Assistants (CLA) across pre-analytic, analytic, and post-analytic phases of high-complexity molecular oncology testing. You'll act as the first point of escalation for technical, operational, and personnel issues, oversee staffing and scheduling, and ensure seamless shift handoffs and workload distribution.
Key responsibilities include performing and overseeing high-complexity molecular assays, ensuring proper instrument operation and calibration, reviewing and verifying test results and QC data, and identifying and resolving deviations that impact test integrity. You'll drive quality and compliance across CLIA, CAP, state, and local regulations, perform QC reviews, lead corrective and preventive actions, support inspection readiness and audits, and contribute to SOP development and updates.
You will lead training and onboarding for new and existing staff, provide hands-on and theoretical instruction for new assays and instrumentation, support process improvement initiatives including assay validation and tech transfer, and partner cross-functionally with Quality, R&D, and Operations teams.
Required qualifications: Active California Clinical Laboratory Scientist (CLS) or CGMBS/generalist license meeting CLIA requirements for high-complexity testing; Bachelor's degree in chemical, biological, physical, clinical laboratory science, or related field; minimum 4 years of clinical laboratory experience including molecular and/or high-complexity testing; CLIA General Supervisor qualifications under 42 CFR 493.1461; demonstrated hands-on experience with molecular biology techniques (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 and organizational skills; strong written and verbal communication with collaborative leadership style.
