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 (amongst many more). 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.

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 proplery 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

Benefits And Perks:

• 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 thousand patients
• Multiple medical benefit options; employee premiums paid 100% of select plans, dependents covered up to 80%
• Extremely generous Family Bonding Leave for eligible employees (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)

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.).

For this position, we offer a total compensation package of up to $205,064 per year, including a base pay range of $128,622 - $150,058 per year.

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.