Process Engineer

Do you want to join one of the fastest-growing molecular diagnostics companies to help transform prenatal and oncology diagnostics that can affect millions of patient lives?

BillionToOne, ranked at the top 5% of Y Combinator companies with $200M+ in funding from prominent VC firms, has developed a DNA molecular counter that increases the cell-free DNA diagnostics resolution by over 1,000 fold. BillionToOne's first product, UNITY™ is the first and only prenatal screen that directly assesses a baby's risk for common and severe recessive gene disorders such as cystic fibrosis and sickle cell, and chromosomal abnormalities like down syndrome from a single tube of blood from the pregnant mother.

Responsibilities:

• Plan and execute scale-up efforts for new NIPT assays.
• Build upon the existing statistical Process Control system to enable ever decreasing failure rates and ever increasing assay performance.
• Source and evaluate external technologies which might benefit COGS, process throughput, assay performance, or other key operational metrics.
• Work with RnD 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. 
• 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 short term and long term solutions. 
• Develop effective training plans for clinical personnel on modified/improved workflows.
• Generate proper documentation for all troubleshooting and qualification.

Requirements:

• Bachelor’s degree or equivalent degree in biology, bioengineering, or related sciences
• At least 3-4 years of experience with molecular biology techniques in a research or clinical laboratory
• Proficiency in R or python
• Strong Statistical Analysis skills 
• Experience designing rigorous, well controlled studies
• 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
• Possess logical troubleshooting skills

Nice-To-Haves:

• Start-up experience
• Knowledge of medical genetics
• Experience in a cell-free DNA setting
• Experience with automation or clinical laboratory experience
• Experience with 6-sigma, Lean, JIT, TPS
• Experience with CLIA/CAP, 510K, PMA, and other regulatory requirements

Benefits and Perks

• Competitive pay
• Generous equity package
• Suite of benefit plans; employee premiums paid 90% of Gold PPO plan
• Extremely generous Medical, Pregnancy, Parental and Family Leaves
• Retirement savings program with 4% Company matching
• Free daily on-site lunches provided from top eateries
• Latest and greatest hardware (laptop, lab equipment, facilities)
• A variety of perks on campus (state of the art gym, restaurant)
• Free on-site EV charging (compatible with all EVs, including Tesla)
• Working with a team of ‘rockstars’ who bring out the best in everyone
• The ability to indirectly or directly change the lives of hundreds of thousand patients
• Open, transparent culture that includes weekly Town Hall meetings

At BillionToOne, we are proud to offer a combination of a (1) base pay range (actual amount offered is based experience and salary/equity options split that the candidate chooses) (2) generous equity options offering, on top of (3) industry leading company benefits (free healthcare options, 401k match, very generous fully paid parental leave etc.).

For this position, the base pay range is: $70,000-$90,000 per year