Senior Scientist, Assay Development
Delfi Diagnostics
Delfi Diagnostics seeks a Senior Scientist to develop and optimize multiomics molecular diagnostic assays for blood-based cancer detection. The role involves designing verification studies, executing analytical validation, and ensuring compliance with regulatory frameworks for in vitro diagnostic applications.
Responsibilities
- Design, execute, and document design verification studies for assay analytical performance
- Develop and optimize multiomics molecular diagnostic assays for early cancer detection
- Collaborate with quality and regulatory teams on design control compliance
- Support analytical validation program under Director leadership
Requirements
- Strong foundation in Next-Generation Sequencing (NGS) and liquid biopsies
- Experience with Design Control frameworks for regulated diagnostic products
- Proficiency in assay development and analytical validation methodologies
- Knowledge of in vitro diagnostic (IVD) regulatory requirements and risk management
- Demonstrated ability to collaborate with quality and regulatory functions
Vacancy posted 21 days ago
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