BillionToOne

Senior Director of Laboratory Operations – Oncology

Menlo Park, California, United States

Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Molecular Diagnostics, Healthcare, BiotechnologyIndustries

Requirements

Candidates must possess a Doctoral degree (PhD or equivalent) in genetics, molecular biology, bioengineering, or a related field. A minimum of 7 years of clinical laboratory operations experience, including direct oversight in regulated environments (CLIA/CAP/NYSDOH), is required. Proven experience in scaling laboratory operations in high-growth settings, with leadership in automation and process engineering, is essential. A deep understanding of CLIA regulations and quality systems, demonstrated by successful inspection readiness and compliance leadership, is necessary. Strong organizational and communication skills, with the ability to inspire and influence diverse teams and functions, are crucial. Experience in budgeting, vendor management, and implementing operational systems for efficiency and cost-effectiveness is also required. Eligibility for California licensure and board certification are considered advantageous, as is hands-on experience with oncology testing, variant interpretation, or molecular assay development.

Responsibilities

The Senior Director of Laboratory Operations – Oncology will provide operational and strategic leadership for CLIA laboratory operations, process engineering, reagent manufacturing, and automation. This role ensures full compliance with CLIA, CAP, NYSDOH, and other regulations, maintaining inspection readiness and high-quality standards. Responsibilities include driving scaling initiatives through automation rollouts, process improvements, and quality system implementation. The position oversees workforce planning, training, and competency assessments, and partners with licensed Laboratory Directors for clinical result interpretation, report sign-out, and regulatory submissions. Collaboration with Product, R&D, Bioinformatics, and QA teams is expected for new test launches and assay optimization. Additionally, the role involves leading budgeting, vendor management, and capital planning to enhance operational efficiency and cost control, while fostering a positive and collaborative team culture.

Skills

CLIA operations
Process engineering
Reagent manufacturing
Automation
Oncology
Molecular diagnostics
Clinical laboratory operations
Regulatory compliance
CAP
NYSDOH

BillionToOne

Molecular diagnostics for prenatal and oncology testing

About BillionToOne

BillionToOne specializes in molecular diagnostics within the healthcare sector, focusing on prenatal screening and oncology testing. Their proprietary QCT technology allows for the detection and quantification of diseases at a single base-pair resolution, enabling the identification of minute variations in DNA. The company offers two main products: Northstar Select™, which helps determine the best initial therapy for patients, and Northstar Response™, which tracks the effectiveness of that therapy. Unlike many competitors, BillionToOne emphasizes accuracy, efficiency, and accessibility in molecular testing, providing diagnostic services directly to healthcare providers. Their goal is to positively impact healthcare by making molecular testing more reliable and available to everyone.

Menlo Park, CaliforniaHeadquarters
2016Year Founded
$380.2MTotal Funding
SERIES_DCompany Stage
Biotechnology, HealthcareIndustries
201-500Employees

Benefits

Competitive pay
Retirement savings package
Parental leave
Free snacks & lunches
Medical, dental, & vision premiums
On campus perks
Free-on-site EV charging

Risks

Emerging biotech startups could threaten BillionToOne's market share.
Rapid technological advancements may render their current technology obsolete.
Expansion into new facilities may face operational challenges or delays.

Differentiation

BillionToOne's QCT technology detects DNA variations at single base-pair resolution.
Their UNITY Fetal Antigen NIPT is the first US cfDNA test for fetal antigen genotyping.
They replace invasive amniocentesis with a safe, affordable blood test for prenatal screening.

Upsides

BillionToOne achieved a billion-dollar valuation with a $130 million funding round.
Their new Austin facility will create 1,000 jobs, boosting production and local economy.
Recognition as Diagnostics Company of the Year highlights their industry leadership.

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