Senior Scientist R&D

Posted 19 days ago

tempusAtlanta (GA)

Molecular and Cellular Biologists Research and Development in Biotechnology (except Nanobiotechnology)

SENIORITY

Senior

SALARY

$94,000.00-$135,000.00

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About the role

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 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. 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.

Summary

Location: Chicago; Atlanta

Type: Full time

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