Senior Process Engineer, Oncology

Ready to redefine what's possible in molecular diagnostics?

Join a team of brilliant, passionate innovators who wake up every day determined to transform healthcare. At Billion To One , we've built something extraordinary—a culture where transparency fuels trust, collaboration drives breakthroughs, and every voice matters in our mission to make life-changing diagnostics accessible to all. We don't just aim for incremental improvements; we strive to build products that are 10x better than anything that exists today.

Our people are our greatest asset: talented scientists, engineers, sales professionals, and visionaries united by an unwavering commitment to changing the standard of care in prenatal and cancer diagnostics. This is where cutting-edge science meets human compassion—every innovation you contribute helps remove fear of unknown from some of life's most critical medical moments. If you're driven by purpose, energized by innovation, and ready to help build the future of precision medicine, this is where you belong.

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. This is considered an onsite role and will require the majority of days to be spent in the office.

Responsibilities:

• 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

Qualifications:

• 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.

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