Senior Scientist - IVD Development

Job Location
San Diego, CA
Job Description

As a Sr Scientist at Illumina, you will work in a dynamic, team-oriented environment and help in the development of molecular diagnostic products. You will work with multi-disciplinary teams to create cutting edge and robust new products and assays for the next generation sequencing platforms offered by Illumina. These products, assays and processes abide to special quality as well as regulatory guidelines. Responsibilities: •Develop new molecular diagnostic products in fast-paced product development environment. •Identify, evaluate, plan experimental details leading to new robust assays for DNA and RNA based on Illumina’s proprietary technologies. •Explore new technologies and identify creative solutions to overcome current limitations. •Design, implement, analyze and present experiments to demonstrate feasibility of new methods and efficiently move products through pipeline up to and including transfer to manufacturing and scale up. •Optimize assay conditions to achieve commercial levels of stability, robustness, and performance. Lead and perform risk analyses and creation of test plans, procedures and reports. •Follow internal product development procedures, as well as ISO13485 and QSR guidelines. •Be both a strong individual contributor as well as a collaborative team member. •Conduct clear and concise communication with colleagues (cross-functional) and supervisors through oral updates, written reports and technical meetings.


Education and Experience: •Ph. D. in the biological sciences/genomics with greater than 8+ years of industrial experience. •3 or more years’ experience in commercial product development, preferably in the molecular diagnostics domain. •Strong background in genetics, genomics, biochemistry and enzymology and a sound understanding of genetic assay development required. •Experience with next-generation sequencing desired. •Working knowledge of ISO13485 and QSR guidelines would be a plus. •Experience with DOE, design for manufacturing and design for robustness techniques. •Must be a self-starter, detail oriented and highly motivated.

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