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Company

Original Job Post

BillionToOne · 3 days ago

Senior Process Engineer, Prenatal

Menlo Park, CA

Full-time

Onsite

Senior Level

$110K/yr - $130K/yr

5+ years exp

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BiotechnologyGenetics

H1B Sponsorship

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Responsibilities

Source and evaluate external technologies which might benefit COGS, process throughput, assay performance, 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

Plan studies in conjunction 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 long term solutions

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Molecular BiologyRPythonStatistical AnalysisStudy DesignData PresentationReport AuthoringGMPISOQuality Management SystemsQuality Management PracticesTroubleshootingProblem-SolvingAttention to DetailCommunicationMentoringStartup experienceMedical genetics knowledgeCell-free DNA experience6-sigmaLeanJITTPSCLIA/CAP510KPMARegulatory requirementsAutomationClinical laboratory experienceAdaptability

Required

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 or python

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 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

Preferred

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

Working with a team of ‘rockstars’ who bring out the best in everyone

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 at 80%

Extremely generous Family Bonding Leave for new parents (16 weeks, paid at 100%)

Retirement savings program including a 4% Company match

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)

Company

BillionToOne

BillionToOne is a precision diagnostics company focused on genetic testing for disease detection.

Founded in 2016

Menlo Park, California, USA

201-500 employees

https://www.billiontoone.com

H1B Sponsorship

BillionToOne has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (1)

2022 (4)

2021 (1)

2020 (2)