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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:
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
Who you are:
You have a B.S., in Biological Sciences, Bioengineeringor 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 biologywith 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 nucleicacid extraction/purification, hybridization, probe and primer design, and technologies for amplification of specific gene sequences.
You have demonstrated experience working under designcontrols, risk management and QMSR compliance and in developing clear work instructions, protocols, reports and other documentation.
You are familiar with and committed to strict adherenceto contamination controls in a molecular assay development environment.
You have experience with GLP (Good Laboratory Practices) and GMP (Good Manufacturing Practices).
Preferred:
You have experience developing and validating FDA clearedand 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
Relocation benefits are not being offered for this position.
The expected salary range for this position based on the primary location of California is $68,300 - $126,800.00. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits (https://roche.ehr.com/default.ashx?CLASSNAME=splash)
Who we are
A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let's build a healthier future, together.
Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants (https://docs.google.com/forms/d/e/1FAIpQLSdZWlsbfQOvFVIQgHE_iDzWUTlhZvj6FytIzjS7xq6IGh1H5g/viewform) .
