Staff Scientist
Illumina
This listing was originally posted on Illumina's careers page. Formulate is an equal opportunity job aggregator and is not involved in the hiring process. Where salary information is estimated, it is derived from BLS industry benchmarks and may differ from actual compensation.
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Upgrade to Pro — $25/moIllumina is seeking a Staff Scientist with expertise in IVD assay development and next-generation sequencing to advance molecular diagnostics and precision oncology. This role is part of the Clinical Solutions team supporting pharma-collaborative projects through assay development, formal verification and validation testing, clinical studies, and regulatory submission.
The Staff Scientist serves as a Study Lead and technical subject matter expert for assigned studies and technical workstreams, with responsibility for experimental design, data analysis and verification, protocol and report authorship, troubleshooting, and cross-functional decision-making within those areas. The role collaborates closely with internal partners, including Quality, Regulatory, Clinical Affairs, Biostatistics, Software, Bioinformatics, and Operations, as well as external partners, to contribute to project goals and deliverables, present results, identify risks and mitigations, and recommend solutions. At the Staff Scientist level, the position includes expanded technical leadership, mentorship, and business acumen responsibilities.
Key Responsibilities:
Provide technical leadership for the initiation, planning, development, troubleshooting, and validation of IVD oncology assays and kits for the clinical market
Apply knowledge of IVD product requirements, clinical laboratory workflows, and clinical market needs to guide assay and product development decisions
Drive technical decision-making and continuous improvement across functional and project teams responsible for designing, executing, troubleshooting, analyzing, and presenting experiments
Lead team execution of formal IVD verification and validation protocols and regulatory reports based on CLSI and other applicable industry standards
Document research progress and study outcomes within a Quality Management System consistent with ISO 13485 expectations
Manage and develop scientists through the design, execution, troubleshooting, analysis, and documentation of verification and validation studies
Author reports and present results, project updates, risks, mitigations, technology assessments, and technical roadmaps to colleagues, senior management, and leadership
Experience/Education:
Typically requires a minimum of 8 years of related experience with a Bachelor’s degree; or 6 years and a Master’s degree; or a PhD with 3 years of experience; or equivalent experience.
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DIAGNOSTICS
Genomic tools, research products, molecular diagnostics, NGS
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