Senior Process Engineer

2 weeks ago

Union City, United States BillionToOne Full time
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 Process Engineer to join our growing superstar Process Engineering team in support of clinical patient testing in our high throughput CLIA lab. The Senior Process Engineer is responsible for (1) Leading the exploration of new technologies which can enable rapid scaling of our commercial assays, (2) Developing and validating new chemistry and/or process changes to enhance product performance, (3) Building out FDA/GMP/ISO compliant Scale-up, V&V, and tech transfer procedures, and (4) Serving as a mentor for junior engineers on the team. This role will enable an individual to flex their skills in process engineering, med device development, statistical analysis, experimental design, and data science (amongst many more). This role will help to build upon the strong technology and execution found within BTO's walls, and will help us pave the way for replicating our prenatal success in the oncology space. This is considered an onsite role and will require the majority of days to be spent in the Union City office.

Responsibilities:
  • Source and evaluate external technologies which might benefit COGS, process throughput, assay performance, or other key operational metrics.
  • Develop the strategies to support 2-3X annual growth in commercial volume.
  • Build upon the existing statistical Process Control system to enable ever decreasing failure rates and ever increasing assay performance.
  • Mentor junior engineers and help to establish strong skills and industry best practices across the growing PE team.
  • Plan studies in conjunction with R&D to identify CPPs, process tolerances, and failure modes during late stage product development.
  • Work with Bioinformatics and data science to translate assay CQAs into impactful and actionable process monitoring tools.
  • Develop new data and information handling tools to aid in efficient sample processing within the clinical laboratory.
  • Apply six sigma, Design-for-quality, and 5S frameworks to existing or new processes to improve both capability, scalability, and quality of molecular diagnostic assays.
  • Support high throughput CLIA lab through troubleshooting instrumentation and re-qualifying instrumentation back into clinical use.
  • Identify root causes for process and instrument errors and develop long term solutions.
Requirements:
  • Bachelor's or Master's (preferred) degree in biology, bioengineering, or related sciences
  • At least 5-6 years of experience with molecular biology techniques in a research or clinical laboratory
  • Proficiency in R or python
  • Proficiency in SQL
  • Strong Statistical Analysis skills
  • Strong Experience designing rigorous, well controlled studies
  • Experience with data presentation and technical report authoring
  • Experience working with GMP, ISO, or equivalent environments, with strong knowledge of Quality Management Systems and practices.
  • Excellent attention to detail
  • Effective written and verbal communication skills
  • Experience mentoring junior team members
  • Possess logical troubleshooting skills
  • Experience with automation or clinical laboratory experience is a bonus
Nice-To-Haves:
  • Start-up experience
  • Knowledge of medical genetics
  • Experience in a cell-free DNA setting
  • Experience with 6-sigma, Lean, JIT, 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, (3) corporate bonus program, on top of (4) industry leading company benefits (free healthcare options, 401k match, very generous fully paid parental leave, etc.).

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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.

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