Process Engineer I

We are looking for a Process Engineer I to join our growing superstar Process Engineering team in support of clinical patient testing in our high throughput CLIA lab. The Process Engineer is responsible for (1) developing process scale-up strategy and capability, (2) reacting to performance trends/declines/anomalies in production data and developing/validating chemistry and/or process changes to regain stable performance, (3) developing FDA/GMP/ISO compliant Scale-up, V&V, and tech transfer procedures, and (4) identifying and evaluating new external technologies which may aid in outpacing BTO's rapid growth in commercial volume. This role will enable an individual to flex their skills in process engineering, med device development, 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, 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:

• 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:

• Minimum Bachelor's degree or equivalent degree in biology, bioengineering, or related sciences (Master's preferred)
• 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
• Experience with automation or clinical laboratory experience is a bonus

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

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 thousands patients
• Multiple medical benefit options; employee premiums paid 100% of select plans, dependents covered up to 80%
• Extremely generous Family Bonding Leave for new parents (16 weeks, paid at 100%)
• Free UNITY Complete NIPT testing for employees & spouses
• 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 $146,611 per year, including a base pay range of $104,040 - $119,646 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.