Senior Scientist R&D
$94k - $135kTempus, Inc.
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.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 characteristicsProvide scientific leadership to cross-functional teamsManage and lead generation of R&D design documentsLead validation team from project inception through launch including sample selection, hands-on laboratory validation, establishing workflow and SOPs, and authoring validation plans and summariesEnsure activities are consistent with project critical path and respond appropriately to changing prioritiesAssist in developing and tracking project budgetsDesign assay performance specificationsEnsure assay development process meets milestones and timelinesTroubleshoot and solve technical issuesMaintain compliant laboratory documents and proceduresProactively improve efficiency, quality and effectiveness of R&D effortsQualifications: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 controlsStrong technical expertise and hands on experience with nucleic acid technologies with a preference towards NGS, PCR, and qPCR techniquesProven ability to apply principles of quality control and quality assurance to development activitiesStrong understanding of FDA, EUA, and other global regulatory requirementsDemonstrated technical and project leadership expertiseGood organization skills, detailed oriented mindsetAbility to thrive in a fast paced environmentTeam driven$94,000.00-$135,000.00The 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.We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. SummaryLocation: Chicago; AtlantaType: Full time
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