Overview In this role you will co-lead the design, development and validation of molecular assays for IVD and CDx programs, ensuring regulatory compliance and robust documentation. You will guide wet-lab efforts and collaborate with cross-functional teams to support FDA submissions and milestones. You'll improve assay performance, drive V&V studies, and help advance Tempus's precision medicine platform. This is an opportunity to shape how diagnostics integrate with AI-driven clinical insights.
Compensation / Benefits- medical and other benefits depending on position
- incentive compensation
- restricted stock units
- salary range discussed
- opportunity to participate in broader benefits
Responsibilities- Lead R&D design and development of molecular assays
- Manage validation activities from inception to launch, including sample selection and SOPs
- Author validation plans and summaries and ensure alignment with critical project timelines
- Provide scientific leadership to cross-functional teams
- Maintain compliant laboratory documents and procedures
- Troubleshoot technical issues and improve R&D efficiency
- Assist in developing and tracking project budgets
- Guide documentation specialists for IVD documentation efforts
Key requirements- PhD in relevant field with 3+ years industry experience or MS with commensurate experience
- FDA-regulated IVD assay development experience with design controls
- Strong expertise in nucleic acid technologies (NGS, PCR, qPCR)
- Ability to apply quality control and assurance principles to development
- Knowledge of FDA, EUA, and global regulatory requirements
- Proven technical and project leadership capabilities
- Organizational skills and detail-oriented mindset
- Ability to thrive in a fast-paced, team-driven environment
- Team driven
- Detail oriented
- Strong organizational skills
- NGS
- PCR
- qPCR
