Lucira Health
  • Berkeley, CA, USA
  • Full Time

About Lucira Health

Lucira Health is a medical technology company focused on the development and commercialization of transformative infectious disease test kits. We have developed a testing platform that produces centralized-laboratory-accurate molecular testing in a single-use and consumer-friendly test kit that is powered by two AA batteries and fits in the palm of a hand. Our LUCIRA Check It (OTC) and LUCIRA COVID-19 All-In-One Test Kit (Rx) are designed to provide a clinically relevant COVID-19 result within 30 minutes from sample collection.

Location

Berkeley, CA

Position Summary

The Associate Scientist/Scientist is a member of the Integration/Assay Development team and will be responsible for on-market product support with some responsibilities in product development projects. This position will be working with R&D, System Engineering, Quality, and other technical teams to drive for successful delivery of responsibilities. The primary responsibility of the Associate Scientist/Scientist will be to support Assay Development in product scale up, case investigation, on-market and next generation product improvements and upgrade activities. The secondary responsibility will be assisting with design and/or execution of assay integration and development studies including V&V of Lucira Health assays. The role may occasionally help with Feasibility and Investigational studies, when needed.

As part of Product Support responsibilities, expertise will be leveraged to solve for technical problems of the existing product portfolio. Analysis of failure trends to avoid issues in the future product portfolio will be also be performed. The Associate Scientist/Scientist will collaborate and attend cross functional meetings to investigate and communicate technical issues, recommend and make corrective actions, conduct troubleshooting experiments and lab work.

As part of Product Development responsibilities, this position will be responsible for assay setups and execution of experiments; experiment design and troubleshooting; reagent preparation, data analysis and presentation; and diligent documentation of studies.

Responsibilities

  • Maintain clear, concise, and complete record of case investigation and/or product development protocols, reports, and lab notebook entries
  • Handle biospecimens in a molecular diagnostic setting
  • Generate and maintain sterile stock of molecular buffers and reaction mixes

Technical Skills

  • Industry experience in product development and troubleshooting
  • Familiarity with the design control life cycle of developing IVD and CE-IVD diagnostic products
  • Familiarity with FDA requirements (ISO13485), 510K submission, and work experience in regulated and QMS compliant environment
  • Understanding of and compliance with principles of GDP
  • Experience with pre-PCR and post-PCR lab procedures
  • Hands on experience and thorough understanding of molecular lab techniques such as PCR setup and troubleshooting, DNA/RNA purification and quantification, ELISA
  • Experience working in a BSL2 environment under GXP conditions and general safety regulations
  • Knowledge of data analysis and modeling in JMP and R is highly desired

Competencies

  • Highly adaptive to a changing project scope and responsibilities
  • Very organized with particular attention to detail in documentation
  • Strong interpersonal and communication skills, both verbal and written
  • Driven with a strong work ethic
  • Excellent time management and organizational skills tailored to collaborate with engineering, product integration, and quality teams
  • A desire to thrive both individually and in a team environment
  • An eagerness to find opportunities to improve and streamline processes

Qualifications

  • BS or MS in Molecular Biology, Biochemistry, Cell Biology, Genetics
  • Associate Scientist candidates: 4+ years of experience in a regulated product development environment with a Master's Degree, or 7+ years of experience in a regulated product development environment with a Bachelor's Degree
  • Scientist candidates: 6+years of experience in a regulated product development environment with a Master's Degree, or 9+ years of experience in a regulated product development environment with a Bachelor's Degree
  • Experience working in an assay development lab and a product support role in the diagnostics/ biotechnology industry will be considered
  • Priority will be given to candidates with experience in regulated product development environments

Lucira Health is an equal opportunity employer and is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status or any other consideration made unlawful by federal, state or local law.


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