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

Responsibilities

In this role, the Research Associate/Senior Research Associate (Assay Integration and Development) will:

  • Work with R&D in collaboration with Assay Research, System Engineering, Quality, and other technical teams to ensure successful drive for completion of assay development milestones
  • Design and execute experiments required for assay integration in the platform, and perform development studies including V&V of Lucira Health assays in compliance with ISO13485, FDA and CE Mark regulations
  • Conduct hands-on lab activities, troubleshooting, authoring protocols and reports. As a member of Development team, the role, will make key contributions to develop, test, and validate new products
  • Independently design and execute experiments in the lab
  • Analyze and present results to scientific teams
  • Prepare reagents, plan and acquire test materials
  • Prepare documents that meet QMS requirements for quality release of materials
  • Maintain clear, concise lab notebook entries, and author test protocols and test reports
  • Handle biospecimens in a molecular diagnostic setting
  • Setup PCR, DNA/RNA purification and quantification, and work in a BSL2 environment under GXP conditions
  • Generate and maintain sterile stocks of molecular buffers and reaction mixes

Competencies

  • Adaptability
  • Detail Orientation
  • Time Management
  • Teamwork and Collaboration
  • Drive to thrive with growth mindset
  • Troubleshooting skills and creative thinking is highly desired
  • Strong organizational and technical writing skills with attention to details
  • Experience in a collaborative, teamwork driven cross-functional environments
  • Able to operate in a dynamic environment with changing priorities, project scopes and responsibilities
  • Demonstrated interest and drive to learn and thrive within a team environment

Qualifications

  • Master's Degree (or Bachelor's Degree with industry experience) in Molecular Biology, Biochemistry, Cell Biology or Genetics required
  • RA position: BS 3+ years/MS 1+ years, and SRA position: BS 5+ years/MS 2+ years demonstrated technical experience working in an assay development lab in the diagnostics/ biotechnology industry
  • Thorough understanding and hands-on experience in setting up molecular assays including PCR reactions, and DNA/RNA purification and quantification, working in a BSL2 environment under GXP conditions and general safety regulations
  • Experience with pre-PCR and post-PCR lab procedures for handling bio-specimens.
  • Industry experience in design control process of developing diagnostic products and V&V testing
  • Experience working in a regulated product development and QMS compliant environment (ISO13485). Knowledge of FDA requirements and experience with 510-K and CE submission for IVD assays are highly preferred
  • Solid understanding of and compliance with principles of GDP
  • Data analysis and modeling experience required. Familiarity with JMP and/or R script preferred
  • Ability to sit and stand for long periods as setting up a reaction can take prolonged periods of time sitting in a chair and pipetting

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.


Lucira Health
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