Senior Scientist, Molecular Assay Development & Validation
Tempus AI, Inc.
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Benefits offered by this job
Job summary
Tempus AI, Inc. seeks a Senior Scientist in Molecular Assay Development within R&D to co-lead assay design and development for IVD/CDx programs.
You will guide wet-lab staff and documentation teams, deliver V&V studies, and ensure regulatory compliance while collaborating across technology development, bioinformatics, quality control, and regulatory affairs. You will lead validation from inception to launch, manage sample selection, SOPs, validation plans, and summaries, and contribute to
Qualifications
- PhD or MS with industry experience in FDA-regulated IVD environments.
- Experience leading assay development for IVD/CDx programs.
- Ability to design and document V&V studies and regulatory submissions.
Responsibilities
- Lead assay development projects and cross-functional teams.
- Guide design documents, validation plans, and summaries.
- Ensure milestones, timelines, and budget alignment.
- Develop assay performance specifications and SOPs.
- Maintain compliant laboratory documents and procedures.
Skills
Education
Tools
Job description
Tempus AI, Inc. seeks a Senior Scientist in Molecular Assay Development within R&D to co-lead assay design and development for IVD/CDx programs.
You will guide wet-lab staff and documentation teams, deliver V&V studies, and ensure regulatory compliance while collaborating across technology development, bioinformatics, quality control, and regulatory affairs. You will lead validation from inception to launch, manage sample selection, SOPs, validation plans, and summaries, and contribute to
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