R&D Development Scientist
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 a Development Scientist within the Assay Development group to co-lead the design and development of assays in support of IVD & CDx programs. In this role you will lead projects with staff scientists that lead the wet lab efforts during development and guide documentation specialists to assist in IVD documentation efforts. You will rise to the challenge of designing, supporting and documenting V&V studies for genotyping assays, ensure project deliverables are compliant with applicable regulations, provide technical reports to support FDA submissions. You are expected to collaborate cross-functionally with members of technology development, bioinformatics, quality control, regulatory affairs, and the clinical lab.
What you’ll do:
Co-lead molecular diagnostic assay development in a hands-on manner through successful FDA submission
Manage and contribute to regulatory documents
Project management
Design assay performance specifications
Ensure assay development process meets milestones and timelines
Troubleshoot and solve technical issues
Maintain compliant laboratory documents and procedures
Proactively improve efficiency, quality and effectiveness of R & D efforts
Qualifications:
PhD in Nucleic Acids Biochemistry, Molecular Biology, or related field -or- MS plus 2+ of relevant industry experience and IVD assay development -or- BS plus 4+ years relevant experience
Experience with development under an FDA regulated environment for IVD products under design controls
In depth knowledge and hands on experience with nucleic acid technologies with a preference towards NGS, PCR, and qPCR techniques
Knowledge of principles of quality control and quality assurance
Understanding of FDA, EUA, and other global regulatory requirements
Demonstrated technical and project leadership expertise
Good organization skills, detailed oriented mindset
Ability to thrive in a fast paced environment
Team driven
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