BillionToOne, Inc.
Senior Director of Laboratory Operations – Oncology
BillionToOne, Inc., Menlo Park, California, United States, 94029
Senior Director of Laboratory Operations – Oncology
Ready to redefine what's possible in molecular diagnostics? Join a team of innovators transforming healthcare. BillionToOne builds a culture where transparency fuels trust, collaboration drives breakthroughs, and every voice matters in making life-changing diagnostics accessible. This role leads the operational scale-up of our high-complexity oncology clinical laboratory, spanning CLIA operations, process engineering, reagent manufacturing, and automation, while ensuring quality and regulatory adherence. The leader will partner with licensed Laboratory Directors to support clinical result interpretation, report sign-out, and regulatory compliance. This is a full-time, onsite position (3–5 days/week) in Menlo Park, CA. Responsibilities
Provide operational and strategic leadership across CLIA laboratory operations, process engineering, reagent manufacturing, and automation. Ensure full compliance with CLIA, CAP, NYSDOH, and other applicable regulations while maintaining inspection readiness and high-quality standards. Drive scaling initiatives to support rapid growth—leading automation rollouts, process improvements, and the implementation of robust quality systems. Oversee workforce planning, training, and competency assessments to cultivate a high-performing, compliant team. Partner with licensed Laboratory Directors to facilitate clinical result interpretation, report sign-out, and regulatory submissions. Collaborate cross-functionally with Product, R&D, Bioinformatics, and QA to launch new tests and continuously optimize assays. Lead budgeting, vendor management, and capital planning to drive operational efficiency and cost control. Foster a positive, collaborative culture that empowers team members to be creative and innovative and to support one another. Requirements
Doctoral degree (PhD or equivalent) in genetics, molecular biology, bioengineering, or a related field. 7+ years of clinical laboratory operations experience, including direct oversight in regulated environments (CLIA/CAP/NYSDOH). Proven track record of scaling laboratory operations in high-growth settings, including automation and process engineering leadership. Deep understanding of CLIA regulations and quality systems, with evidence of successful inspection readiness and compliance leadership. Strong organizational and communication skills, with demonstrated ability to inspire and influence across diverse teams and functions. Proven ability to build and lead positive, collaborative, high-performing teams where creativity and mutual support are prioritized. Experience in budgeting, vendor management, and implementing operational systems that enhance efficiency and cost-effectiveness. Nice-To-Haves
Valid or eligible California licensure (e.g., CGMBS, CGMB, or MD/DO); eligibility will also be considered. Board certification (ABMGG, ABP in Molecular Genetic Pathology, or equivalent). Hands-on experience with oncology testing, variant interpretation, or molecular assay development. Open, transparent culture that includes weekly Town Hall meetings. Competitive benefits including multiple medical plans with employer-paid premiums for select plans, dependent coverage up to 80%. Generous parental leave, fertility benefits, and retirement savings with 4% company match. Additional on-site amenities and perks on campus (lunches, gym, EV charging, etc.). Compensation and Benefits
We offer a total compensation package of up to $462,120 per year, including a base pay range of $239,292 - $260,100 per year, plus equity and bonuses. Benefits include generous paid parental leave, 401(k) match, and comprehensive health options. About BillionToOne
BillionToOne
is a next-generation molecular diagnostics company on a mission to make powerful, accurate diagnostic tests accessible to everyone. Our QCT molecular counting technology enhances disease detection resolution by over a thousandfold using cell-free DNA, transforming patient care worldwide. Our impact includes Unity Complete, a non-invasive prenatal screen for fetal risk of common recessive conditions and aneuploidies, and Northstar, a liquid biopsy test for oncology that combines treatment selection with real-time monitoring. Our growth includes reaching $125 million in Annual Recurring Revenue, raising nearly $400 million in funding, and a recent Series D round in 2024. We are backed by premier investors and recognized as a great place to work. Headquartered in Menlo Park with facilities in Union City, California, BillionToOne continues to push the boundaries of molecular diagnostics. We value collaboration, bold thinking, and patient-centered science. Ready to help us change the world, one diagnosis at a time? Apply for this job
Note: This application page contains form fields and instructions for submission and is not included in this refined job description.
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Ready to redefine what's possible in molecular diagnostics? Join a team of innovators transforming healthcare. BillionToOne builds a culture where transparency fuels trust, collaboration drives breakthroughs, and every voice matters in making life-changing diagnostics accessible. This role leads the operational scale-up of our high-complexity oncology clinical laboratory, spanning CLIA operations, process engineering, reagent manufacturing, and automation, while ensuring quality and regulatory adherence. The leader will partner with licensed Laboratory Directors to support clinical result interpretation, report sign-out, and regulatory compliance. This is a full-time, onsite position (3–5 days/week) in Menlo Park, CA. Responsibilities
Provide operational and strategic leadership across CLIA laboratory operations, process engineering, reagent manufacturing, and automation. Ensure full compliance with CLIA, CAP, NYSDOH, and other applicable regulations while maintaining inspection readiness and high-quality standards. Drive scaling initiatives to support rapid growth—leading automation rollouts, process improvements, and the implementation of robust quality systems. Oversee workforce planning, training, and competency assessments to cultivate a high-performing, compliant team. Partner with licensed Laboratory Directors to facilitate clinical result interpretation, report sign-out, and regulatory submissions. Collaborate cross-functionally with Product, R&D, Bioinformatics, and QA to launch new tests and continuously optimize assays. Lead budgeting, vendor management, and capital planning to drive operational efficiency and cost control. Foster a positive, collaborative culture that empowers team members to be creative and innovative and to support one another. Requirements
Doctoral degree (PhD or equivalent) in genetics, molecular biology, bioengineering, or a related field. 7+ years of clinical laboratory operations experience, including direct oversight in regulated environments (CLIA/CAP/NYSDOH). Proven track record of scaling laboratory operations in high-growth settings, including automation and process engineering leadership. Deep understanding of CLIA regulations and quality systems, with evidence of successful inspection readiness and compliance leadership. Strong organizational and communication skills, with demonstrated ability to inspire and influence across diverse teams and functions. Proven ability to build and lead positive, collaborative, high-performing teams where creativity and mutual support are prioritized. Experience in budgeting, vendor management, and implementing operational systems that enhance efficiency and cost-effectiveness. Nice-To-Haves
Valid or eligible California licensure (e.g., CGMBS, CGMB, or MD/DO); eligibility will also be considered. Board certification (ABMGG, ABP in Molecular Genetic Pathology, or equivalent). Hands-on experience with oncology testing, variant interpretation, or molecular assay development. Open, transparent culture that includes weekly Town Hall meetings. Competitive benefits including multiple medical plans with employer-paid premiums for select plans, dependent coverage up to 80%. Generous parental leave, fertility benefits, and retirement savings with 4% company match. Additional on-site amenities and perks on campus (lunches, gym, EV charging, etc.). Compensation and Benefits
We offer a total compensation package of up to $462,120 per year, including a base pay range of $239,292 - $260,100 per year, plus equity and bonuses. Benefits include generous paid parental leave, 401(k) match, and comprehensive health options. About BillionToOne
BillionToOne
is a next-generation molecular diagnostics company on a mission to make powerful, accurate diagnostic tests accessible to everyone. Our QCT molecular counting technology enhances disease detection resolution by over a thousandfold using cell-free DNA, transforming patient care worldwide. Our impact includes Unity Complete, a non-invasive prenatal screen for fetal risk of common recessive conditions and aneuploidies, and Northstar, a liquid biopsy test for oncology that combines treatment selection with real-time monitoring. Our growth includes reaching $125 million in Annual Recurring Revenue, raising nearly $400 million in funding, and a recent Series D round in 2024. We are backed by premier investors and recognized as a great place to work. Headquartered in Menlo Park with facilities in Union City, California, BillionToOne continues to push the boundaries of molecular diagnostics. We value collaboration, bold thinking, and patient-centered science. Ready to help us change the world, one diagnosis at a time? Apply for this job
Note: This application page contains form fields and instructions for submission and is not included in this refined job description.
#J-18808-Ljbffr