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Senior Process Engineer, Oncology

BillionToOne

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Location:
United States , Menlo Park

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

126721.00 - 168961.00 USD / Year
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Job Description:

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/CAP lab. The Senior Process Engineer is responsible for (1) Developing, maintaining and using process monitoring tools to continuously improve the performance of our tests, (2) Building out CLIA/CAP compliant scale-up, V&V, and tech transfer procedures, (3) Developing and validating new process and/or chemistry changes to enhance product performance, (4) Leading cross-functional efforts that integrate automation, LIMS, service engineering, and scientific R&D to enhance the operations of the CLIA lab, and (5) Serving as a mentor for junior engineers on the team. This role will enable an individual to flex their skills in process engineering, statistical analysis of large, 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.

Job Responsibility:

  • Develop strategies to support >3X annual growth in commercial volume
  • Build tools and processes to enhance statistical Process Control to enable increasing assay performance and decreasing failure rates during rapid scale-up
  • 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
  • Source and evaluate external technologies which might benefit COGS, process throughput, assay performance, or other key operational metrics
  • 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 and/or python
  • Proficiency in handling complex data sets, including back-end data wrangling, database querying, and dashboard development
  • 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 highly-regulated 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

Nice to have:

  • Start-up experience
  • Experience in a cell-free DNA setting
  • Knowledge of molecular oncology
  • Experience with CLIA/CAP, 510K, PMA, and other regulatory requirements
  • Experience with 6-sigma, Lean, JIT
  • Experience with automation or clinical laboratory experience is a bonus
What we offer:
  • Working alongside brilliant, kind, passionate and dedicated colleagues, in an empowering environment, toward a global vision, striving for a future in which transformative molecular diagnostics can help millions of patients
  • 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 up to 80%
  • Extremely generous Family Bonding Leave for new parents (16 weeks, paid at 100%)
  • Supplemental fertility benefits coverage
  • Retirement savings program including a 4% Company match
  • Increase paid time off with increased tenure
  • Latest and greatest hardware (laptop, lab equipment, facilities)
  • Free daily on-site lunches provided from top eateries
  • A variety of perks on campus (state of the art gym, restaurant)
  • Free on-site EV charging (compatible with all EVs, including Tesla)
  • generous equity options offering
  • corporate bonus program

Additional Information:

Job Posted:
December 26, 2025

Employment Type:
Fulltime
Work Type:
On-site work
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