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
In this hybrid and highly collaborative role contributing to Product Development and Product Support teams in R&D- Assay DEV., the Research Associate/Senior Research Associate (Supporting Product Development & Product Support Teams) will:
Work closely with cross functional teams including System Engineering, QE, QA, QC
Assist with assay development activities including assay integration in our molecular testing platform, V&V, and troubleshooting studies
Contribute to the Product Support team by taking part in optimization of on-market products
Design and execution, reagent preparation and assay setup as well as complete data analysis and presentation of results to the scientific team
Will serve as a vital part of the Lucira Health team, with key contributions to develop, test and validate new products, and optimize/support on-market products
Troubleshoot to resolve product issues and optimize assay design and components
Independently design and execute experiments in the lab. Perform data analysis and present results to scientific teams
Prepare reagents, plan and acquire test materials.
Handle biospecimens in a molecular diagnostic setting
Prepare documents, perform data analysis and present results to the scientific team
Maintain clear, concise lab notebook entries, and author test protocols and test reports
Complete PCR setup, DNA/RNA purification and quantification, work in a BSL2 environment under GXP conditions and general safety regulations
Generate and maintain sterile stocks of molecular buffers and reaction mixes
- Detail Orientation
- Strong (Verbal and Written) Communication
- Time Management
- Teamwork and Collaboration
- Growth mindset
- RA - BS + 3 years/MS + 1 year demonstrated technical experience working with molecular biology techniques in an assay development lab in the diagnostics/ biotechnology industry
- SRA - BS + 5 years/MS + 3 years demonstrated technical experience working with molecular biology techniques in an assay development lab in the diagnostics/ biotechnology industry
- Industry experience in design control process of developing diagnostic products, including assay integration, late-stage studies and V&V testing. Experience in product support is highly desirable.
- Experience working in a regulated product development and QMS compliant environment (ISO13485). Knowledge of FDA and CE requirements with 510K submission for IVD assays are highly desired.
- Demonstrated troubleshooting skills to resolve product issues and utilization of creative thinking to optimize product design is highly desired
- Familiarity and/or experience with process development is highly desired.
- Experience handling biospecimens in a molecular diagnostic setting, and familiar with pre-PCR and post-PCR procedures and rooms
- Firsthand experience in molecular biology lab, and mastery of molecular techniques including PCR reactions, DNA/RNA purification and quantification, and principles of working in a BSL2 environment under GXP regulations.
- Solid understanding of, and compliance with principles of GDP
- Data analysis and modeling experience required. Familiarity with JMP, R or MAT LAB preferred
- Previous successful experience operating in a dynamic environment with changing priorities, project scopes and responsibilities
- Strong organizational and technical writing skills with attention to details
- Experience in a collaborative, teamwork driven cross-functional environment within assay, Engineering, and Quality teams
- Demonstrated interest and drive to learn and thrive within a team environment
- 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
Travel Requirements: (Negligible)