Assay Transfer 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 an Assay Transfer Scientist within the Molecular Assay Development group to lead the transfer and validation of NGS assays from the primary Tempus lab location in Chicago, IL to other clinical labs. In this role you will work with NGS/molecular scientists to become an expert in each assay and subsequently train clinical laboratory staff at the satellite location(s). You will also be responsible for designing clinical validation in accordance with various regulatory agency requirements, managing and supporting the execution of these validations, and preparing technical reports. You are expected to collaborate cross-functionally with members of technology development, bioinformatics, quality control, regulatory affairs, and the clinical labs at each location involved in transfer. This position is based in Tempus’ Raleigh-Durham, NC location in Research Triangle Park. Travel may be required >50% of time.       

What you’ll do:

• Lead molecular diagnostic assay transfer and validation in a hands-on manner through successful clinical testing at the transferred location
• Prepare clinical sample artifacts with a focus on precision to meet validation study needs, which may include preparing dilutions, aliquoting, creating admixtures, etc. 
• Manage and/or contribute to validation planning and reporting documents
• Ensure clinical staff is trained and competent in assay operation prior to validation 
• Document assay performance specifications
• Ensure assay transfer/validation meets milestones and timelines
• Troubleshoot and solve technical issues
• Maintain compliant laboratory documents and procedures
• Proactively improve efficiency, quality and effectiveness of transfer efforts

Qualifications:

• PhD in Nucleic Acids Biochemistry, Molecular Biology, or related field -or- MS plus 2 years of relevant industry experience and NGS assay development -or- BS plus 4-8 years relevant experience
• Experience with development in a CAP/CLIA regulated environment under design controls
• In depth knowledge and hands on experience with nucleic acid technologies with a preference towards NGS and PCR techniques
• Knowledge of principles of quality control and quality assurance
• Demonstrated technical and project leadership expertise
• Good organization skills, detailed oriented mindset
• Ability to thrive in a fast paced environment
• Team driven

#LI-SH1#LI-Hybrid#LI-Remote#LI-Onsite