Senior Scientist, Assay Development

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

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. We look to innovative diagnostics which can shape the future of healthcare and change lives.

Roche is seeking a motivated scientist to join the Molecular Diagnostic group in San Diego. This individual will be responsible for working on all aspects (including Assay Design, Assay Optimization & Sample Preparation) of LumiraDx’s proprietary amplification technology, qSTAR. This role requires expert scientific knowledge as well as technical expertise in design and execution of experiments in the areas of molecular and cell biology, assay development, and extraction/lysis/purification of genomic material. This role requires >80% of bench-level work. An ideal candidate will be able to demonstrate technical skills in the lab, and also aspire to grow as an independent researcher who can take more leadership opportunities in the future.

• You will design and conduct hands-on experiments to achieve project goals and timeline

• You will execute experiments efficiently with high reproducibility, in collaboration with R&D team

• You will work in a BSL-2/2+ laboratory with potentially infectious agents, and other biological fluids of human and animal origin

• You will achieve project objectives by troubleshooting experiments and testing practical and creative solutions

• You will write and review technical documents including protocols, reports, methods, specifications, SOPs, and technical assessments

• You will present effectively, 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

This position is based in Solana Beach, CA.

Relocation benefits are not being offered for this role.

Who You Are:
(Required)

• 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 a 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 hybridization, probe and primer design, and technologies for amplification of specific gene sequences. 

• You have demonstrated experience working under design controls, risk management and QSR compliance and in developing clear work instructions, protocols, reports and other documentation.

• You are familiar with contamination controls in a molecular assay development environment.

• You have experience with GMP (Good Manufacturing Processes) and GLP (Good Laboratory Processes).
   

Preferred:

• 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

WORK ENVIRONMENT
 

The essential functions of the job are usually performed in an environmentally controlled facility wh