Assay Development Staff Scientist, IVD at Tempus
Passionate about precision medicine and advancing the healthcare industry?
Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
We are looking for an Assay Development Staff Scientist, IVD to lead the design and development of IVD assays in support of our IVD & CDx programs. In this role you will lead the wet-lab R&D efforts on IVD development as well as collaborate cross-functionally with members of technology development, bioinformatics, quality control, regulatory affairs and the clinical lab. You will rise to the challenge of designing, supporting and documenting V&V studies for our genotyping assay, providing technical reports to support FDA submissions. You are expected to divide your time between working in the lab and at the desk and guiding junior team members in their execution of NGS experiments to support IVD development.
What You’ll Do:
- Lead molecular diagnostic assay development in a hands-on manner through successful FDA submission
- Manage and contribute to regulatory documents
- Project management; personnel management skills preferred
- Design assay performance specifications
- Ensure assay development process meets milestones and timelines
- Troubleshoot and solve technical issues
- Maintain compliant laboratory documents and procedures
- Pro-actively improve efficiency, quality and effectiveness of R & D efforts
- PhD in Nucleic Acids Biochemistry, Molecular Biology, or related field
- Minimum of 5 years of relevant industry experience and IVD assay development
- Experience with development under an FDA regulated environment for IVD product under design control
- In depth knowledge and hands on experience with nucleic acid technologies with a preference with NGS, PCR, and qPCR techniques
- Knowledge of principles of quality control and quality assurance
- Understanding of FDA and global regulatory requirements
- Demonstrated technical, managerial and leadership expertise
- Good organization skills, detailed orientated mindset