Senior Process Engineer, Oncology
BillionToOne
Summary
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, high-throughput laboratory scaleup, process improvement, statistical analysis, experimental design, and data science. This role will help to build upon the strong technology and execution found within BTO's walls. The Senior Process Engineer is an onsite position at our Menlo Park location.
Job description
Responsibilities
- Source and evaluate external technologies which might benefit COGS, process throughput, assay performance, turnaround time, 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.
- Facilitate technology transfer between R&D and the clinical laboratory, identifying CPPs, process tolerances, and failure modes while ensuring that new workflows are properly implemented in the production environment.
- 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 and process monitoring 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.
- Lead thorough root cause analyses to identify and solve process issues, with a mindset for long-term solutions.
Qualifications
- Bachelor's, Master's or Ph.D. 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, 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 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
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
- Experience with automation or clinical laboratory experience is a bonus
Requirements
- Bachelor's, Master's or Ph.D. 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, 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 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
Benefits
- Medical, Dental & Vision
- 401(k) Matching
- Stock Options
- Corporate Bonus Program
- Paid Parental Leave
- Fertility Benefits
- Paid Time Off
- Free Daily On-Site Lunches
- On-Site Gym
- On-Site EV Charging
Company overview
BillionToOne is a precision diagnostics company headquartered in Menlo Park, California, founded in 2016 with a mission to make molecular diagnostics more accurate, efficient, and accessible. The company has developed a proprietary Quantitative Counting Templates (QCT) molecular counting platform that can accurately count DNA molecules at the single-molecule level, enabling unprecedented sensitivity in disease detection. BillionToOne operates as a publicly traded company on NASDAQ under the symbol BLLN, having completed a successful IPO in 2025. The company's diagnostic platforms include UNITY Complete for non-invasive prenatal testing, which assesses fetal risk for recessive conditions and aneuploidies from a single maternal blood sample, and Northstar oncology products for cancer therapy selection and treatment response monitoring. With over 500 employees and multiple CLIA/CAP accredited laboratories, BillionToOne represents a significant advancement in quantitative molecular diagnostics, combining breakthrough science with scalable commercial operations to transform healthcare delivery.