Principal Scientist - Bioanalytical Quality Scientist
Build our future together:
Regeneron is seeking a Senior Principal Scientist to serve as a Biomarker Assay Quality Lead within Translational Medicine. In this highly collaborative, matrixed role, you will help ensure that biomarker assays supporting clinical development are scientifically rigorous, fit for purpose, and executed to consistently high quality standards. You will provide independent oversight of externally led assay development, validation, implementation, and quality monitoring across a broad range of platforms, including molecular and next-generation sequencing assays, immunohistochemistry and AI-enabled pathology, ligand-binding assays, proteomics, LC-MS and metabolomics, flow cytometry, qPCR/qRT-PCR, and emerging technologies.
You will partner with internal teams and external laboratories to strengthen assay strategies, minimize the impact of preanalytical variables, and deliver reliable biomarker data that support clinical endpoints and development decisions. From project initiation through closeout, you will review and approve scopes of work, development and validation plans, quality-control strategies, final validation reports, and biomarker analytical reports.
When & where:
- Location: Tarrytown, NY
- Work model/flexibility: 4 days onsite
Discover your role:
- Provide independent scientific and quality oversight for biomarker assay development, validation, implementation, and ongoing performance across multiple technology platforms.
- Review and approve assay-development scopes of work, analytical validation plans, quality-monitoring plans, final validation reports, and biomarker analytical reports.
- Define fit-for-purpose validation strategies and design pilot studies to identify and control preanalytical variables that may affect assay performance.
- Partner with Global Clinical Operations and external central, specialty, contract ...
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