Sr Scientist
About The Position
We advance science so that we all have more time with the people we love. Roche Diagnostics acquired LumiraDx in 2024 for its unique Point of Care diagnostics platform. You will be an instrumental member of the R&D team to develop the molecular assays and next generation POC diagnostic platform. Roche is seeking a motivated scientist to join the Molecular Diagnostic group in San Diego. This individual will be responsible for working on all IVD product development aspects (including assay/systems optimization, validation & verification, and regulatory submissions) of LumiraDx’s proprietary amplification technology, qSTAR on the Point-Of -Care instrument. This role requires deep scientific knowledge as well as technical expertise in designing and executing experiments in the areas of molecular and cell biology, , and extraction/lysis/purification of genomic material. This role requires >80% of bench-level work. An ideal candidate will demonstrate technical skills in the lab, data analysis and report writing abilities and also aspire to grow as an independent product developer who can take more leadership opportunities in the future. The Opportunity Your responsibilities in this role will include:
Requirements
- You have a B.S., in Biological Sciences, Bioengineering or related field with 6+ years of experience; or a M.S with 4+ years of experience; or a PhD with 2+ years of experience in an IVD, medical devices or pharma/biotech environment
- You have demonstrated experience in molecular biology with strong technical expertise in Molecular Diagnostic assays (PCR, qPCR, ddPCR, and/or other isothermal/non-isothermal amplification techniques).
- You have demonstrated experience in principles of nucleic acid extraction/purification, hybridization, probe and primer design, and technologies for amplification of specific gene sequences.
- You have demonstrated experience working under design controls, risk management and QMSR compliance and in developing clear work instructions, protocols, reports and other documentation.
- You are familiar with and committed to strict adherence to contamination controls in a molecular assay development environment.
- You have experience with GLP (Good Laboratory Practices) and GMP (Good Manufacturing Practices).
Nice To Haves
- You have experience developing and validating FDA cleared and CE Marked IVD products.
- You have experience working in a BSL-2/2+ environment.
- You have experience of using statistical tools (JMP, Excel, Minitab, etc…).
- You have experience of using bioinformatic tools for assay designs.
- You have experience with designing QC protocols and technology transfer.
- You have experience leading and/or managing projects
Responsibilities
- You will design and conduct hands-on experiments to achieve project goals and timelines
- You will work in a BSL-2/2+ laboratory with potentially infectious agents, and other biological fluids of human and animal origin
- You will execute experiments efficiently with high reproducibility, in collaboration with other members of R&D team
- You will accurately and consistently record experimental methods, materials and results in electronic laboratory notebooks.
- You will analyze data, evaluate results, form conclusions and implement/document process improvements.
- You will integrate previous and current results to determine next experimental steps and the impact of long-range project goals
- You will write and review technical documents including protocols, reports, methods, specifications, SOPs, and technical assessments
- You will present at group or departmental meetings, providing progress updates and feedback on a regular basis
- You will conduct data processing, create visualizations, design experiments (DOE), and perform statistical analysis (such as ANOVA) using tools like JMP, Excel, and others as needed
- You may manage processes for projects, requiring delegation of work and review of others' work product
- You will perform routine laboratory upkeep and maintenance duties as described in SOPs or assigned by R&D leadership
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
