Senior Process Engineer, Oncology
About The Position
BillionToOne is seeking a Senior Process Engineer to support clinical patient testing in its high-throughput CLIA laboratory. This role leads exploration of technologies that can scale commercial assays, develops and validates chemistry or process changes to improve product performance, and builds FDA/GMP/ISO-compliant scale-up, verification and validation, and technology-transfer procedures. The engineer also mentors junior team members and helps strengthen process engineering practices as the team grows. The position applies process engineering, laboratory scale-up, process improvement, statistical analysis, experimental design, and data science to support assay performance and operational growth. It is an onsite role at the company’s Menlo Park location.
Requirements
- Bachelor’s, Master’s, or Ph.D. in biology, bioengineering, or a related science.
- At least 5–6 years of experience with molecular biology techniques in a research or clinical laboratory.
- Proficiency in R, Python, or an adjacent coding language.
- Strong statistical analysis skills.
- Strong experience designing rigorous, well-controlled studies in a molecular biology environment.
- Experience with data presentation and technical report authoring.
- Experience working in 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.
- Logical troubleshooting skills.
Nice To Haves
- Start-up experience.
- Knowledge of medical genetics.
- Experience in a cell-free DNA setting.
- Experience with Six Sigma, Lean, JIT, or TPS.
- Experience with CLIA/CAP, 510(k), PMA, or other regulatory requirements.
- Experience with automation or in a clinical laboratory.
Responsibilities
- Source and evaluate external technologies that could improve cost of goods, throughput, assay performance, turnaround time, or other operational metrics.
- Develop strategies to support two- to three-fold annual growth in commercial volume.
- Build on the statistical Process Control system to reduce failure rates and improve assay performance.
- Mentor junior engineers and establish strong skills and industry best practices across the Process Engineering team.
- Facilitate technology transfer between R&D and the clinical laboratory, identifying critical process parameters, process tolerances, and failure modes, and ensuring new workflows are properly implemented in production.
- Work with Bioinformatics and Data Science to translate assay critical quality attributes into actionable process-monitoring tools.
- Develop data and information-handling tools for efficient sample processing and process monitoring in the clinical laboratory.
- Apply Six Sigma, Design-for-Quality, and 5S frameworks to improve process capability, scalability, and quality of molecular diagnostic assays.
- Lead thorough root-cause analyses to identify and solve process issues with a focus on long-term solutions.
Benefits
- Multiple medical benefit options, including select plans with employee premiums paid in full and dependent coverage up to 80%.
- 16 weeks of paid Family Bonding Leave at 100% for eligible employees.
- Supplemental fertility benefits coverage.
- Retirement savings program with a 4% company match.
- Paid time off that increases with tenure.
- Latest hardware, including laptops and laboratory equipment, and facilities.
- Free daily on-site lunches.
- On-campus amenities including a state-of-the-art gym and restaurant.
- Free on-site EV charging.
- Equity options offering.
- Corporate bonus program.
- Free healthcare options.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
