Senior Scientist, Molecular Assay Development in R&DPassionate 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 Senior Scientist within the Molecular 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 molecular assays, ensure project deliverables are compliant with applicable regulations, and 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:- Maintain overall knowledge of the assay characteristics
- Provide scientific leadership to cross-functional teams
- Manage and lead generation of R&D design documents
- Lead validation team from project inception through launch including sample selection, hands-on laboratory validation, establishing workflow and SOPs, and authoring validation plans and summaries
- Ensure activities are consistent with project critical path and respond appropriately to changing priorities
- Assist in developing and tracking project budgets
- 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 with 3+ years industry experience -or- MS with industry experience commensurate with requirements
- Demonstrated leadership capabilities in assay development in an FDA regulated environment for IVD products under design controls
- Strong technical expertise and hands on experience with nucleic acid technologies with a preference towards NGS, PCR, and qPCR techniques
- Proven ability to apply principles of quality control and quality assurance to development activities
- Strong 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
$94,000.00-$135,000.00
The expected salary range above is applicable if the role is performed from Illinois and may vary for other locations (California, Colorado, New York). Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.
