Senior Process Engineer, Oncology

BillionToOne•Menlo Park, CA

63d•Onsite

About The Position

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.

Requirements

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.
Excellent attention to detail
Effective written and verbal communication skills
Experience mentoring junior team members
Possess logical troubleshooting skills
Experience with automation or clinical laboratory experience is a bonus

Nice To Haves

Start-up experience
Experience in a cell-free DNA setting
Knowledge of molecular oncology
Experience with CLIA/CAP, 510K, PMA, and other regulatory requirements
Experience with 6-sigma, Lean, JIT

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

Benefits

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%)
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)