Senior Manager/Associate Director of Process Engineering (PE)

BillionToOne is a next-generation molecular diagnostics company dedicated to developing powerful and accurate diagnostic tests that are accessible to all. Our innovative QCT molecular counting technology significantly enhances the resolution of disease detection using cell-free DNA by over a thousandfold. This groundbreaking technology is integral to our product offerings, including one of our flagship products, Unity Complete™, the only non-invasive prenatal screen capable of assessing fetal risk for both common recessive conditions and aneuploidies from a single maternal blood sample. Leveraging the same molecular counting technology, we've expanded our impact into oncology in 2023 with a pioneering liquid biopsy test, Northstar, that combines treatment selection with monitoring. To date, over 500,000 patients have benefited from our innovative and precise diagnostic tests, and our Annual Recurring Revenue (ARR) has grown from $0 to $125 million in the last ~4 years.

BillionToOne has successfully raised close to $400 million in funding, with a notable $130 million Series D round completed in June 2024, resulting in a company valuation of over $1 billion. This funding has come from prestigious global institutional investors, including Hummingbird, Adams Street Partners, Neuberger Berman, Baillie Gifford, and Premji Invest. BillionToOne has recently been recognized by Forbes as one of America's Best Startup Employers for 2024, highlighting the company's exceptional work environment and commitment to innovation.

Our team has grown significantly and we now proudly employ over 400 highly skilled individuals. Despite substantial growth, we have successfully maintained the unique culture that has defined BillionToOne from inception, continuing to cultivate a team that is not only diverse and passionate but also innovative. Headquartered in Menlo Park, California, with an additional facility in Union City, California, BillionToOne remains at the forefront of significant advances in molecular diagnostics, evidenced by the recent announcement of clinical outcomes data for its Unity Fetal Risk Screen and new advancements in cancer diagnostics. For more detailed information about BillionToOne and its groundbreaking work, please visit our website at www.billiontoone.com.

We are looking for a Senior Manager/Associate Director of Process Engineering (PE) to lead and strategically guide our high-performing Process Engineering team, driving the next level of clinical patient testing within our high-throughput CLIA lab for our groundbreaking oncology tests (level commensurate with experience and strategic acumen). This role is crucial in scaling our commercial Northstar assays and advancing our success from prenatal testing into the oncology space. As the functional head of this group, you will provide strategic leadership, spearhead technology exploration, and hire and mentor a growing team of talented scientists, engineers, and associates. This position offers a unique opportunity to combine your expertise in process improvements, assay development, and experimental design with leadership and innovation. The Senior Manager/Associate Director of Process Engineering is an onsite position at our Menlo Park location.

Responsibilities:

• Technology & Strategic Growth: Source, evaluate, and implement technologies to support 3X+ annual growth in commercial volume, ensuring scalability, efficiency, and optimized assay performance.
• Assay Performance & Monitoring: Enhance existing statistical process control systems to reduce failure rates and improve assay performance continuously.
• Mentorship: Lead, mentor, and develop junior scientists and engineers, fostering a culture of excellence and best practices within the growing PE team.
• Collaboration & Data-Driven Insights: Work closely with Bioinformatics, Data Science, and R&D teams to translate assay critical quality attributes into actionable process monitoring tools, while identifying critical process tolerances during late-stage product development.
• Process Improvement: Apply Six Sigma, Design-for-Quality, and 5S frameworks to optimize existing or new processes, enhancing the capability, scalability, and quality of molecular diagnostic assays.
• Lab Support & Troubleshooting: Support the high-throughput CLIA lab by troubleshooting and identifying root causes of process and instrument errors, developing long-term solutions for improvement.

Requirements:

• Education: Master’s or PhD (preferred) in Biology, Bioengineering, or a related field.
• Experience: At least 5-6 years of experience with molecular biology techniques in research or clinical settings (outside of academia).
• Leadership: Demonstrated ability to hire, lead, mentor, and develop a team, fostering a culture of growth and innovation.
• Technical Skills: Demonstrated proficiency in R or Python, with strong statistical analysis skills and experience in designing rigorous, well-controlled studies.
• Regulatory Knowledge: Experience with GMP, ISO, or similar environments, and a good understanding of Quality Management Systems.
• Communication: Excellent attention to detail with strong written and verbal communication skills.

Nice-To-Haves:

• Start-up experience.
• Experience in a cell-free DNA setting.
• Experience in lab automation or clinical laboratory settings.
• Familiarity with Six Sigma, Lean, JIT, or TPS.
• Experience with CLIA/CAP, 510K, PMA, and other regulatory requirements.

Benefits And Perks:

• Working with a team of ‘rockstars’ who bring out the best in everyone
• Open, transparent culture that includes weekly Town Hall meetings
• The ability to indirectly or directly change the lives of hundreds of thousands patients
• Multiple medical benefit options; employee premiums paid 100% of select plans, dependents covered at 80%
• Extremely generous Family Bonding Leave for new parents (16 weeks, paid at 100%)
• Retirement savings program including a 4% Company match
• Free daily on-site lunches provided from top eateries
• Latest and greatest hardware (laptop, lab equipment, facilities)
• A variety of perks on campus (state of the art gym, restaurant)
• Free on-site EV charging (compatible with all EVs, including Tesla)

At BillionToOne, we are proud to offer a combination of a (1) base pay range (actual amount offered is based on experience and salary/equity options split that the candidate chooses) (2) generous equity options offering, on top of (3) industry leading company benefits (free healthcare options, 401k match, very generous fully paid paternal leave etc.).

For this position, the total compensation including equity and bonus is $300,000-$350,000 per year with the base salary range of $150,000-$200,000 per year (based on the level and experience).

BillionToOne is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.