Senior Scientist, Molecular Assay Development — IVD/CDx

Tempus AI; Chicago (IL); On-site; USD 94,000 - 135,000; Full time

Job summary

Tempus AI is seeking a Senior Scientist in the Molecular Assay Development group to co-lead design and development of assays for IVD and CDx programs. You will lead projects with staff scientists that guide documentation specialists and ensure V&V studies are compliant for FDA submissions.

You will collaborate cross-functionally with technology development, bioinformatics, quality control, regulatory affairs, and the clinical lab, driving milestones and documentation.

Qualifications

• PhD in Nucleic Acids Biochemistry or Molecular Biology with 3+ years of industry experience, or MS with relevant experience.
• Experience in FDA-regulated environments for IVD products under design controls.
• Hands-on expertise with nucleic acid technologies, especially NGS, PCR, and qPCR.
• Strong quality control and quality assurance for development activities.
• Knowledge of FDA, EUA and other global regulatory requirements.
• Proven technical leadership and project management capabilities.
• Organized, detail-oriented, and able to work in a fast-paced team.
• Team-driven with cross-functional collaboration.

Responsibilities

• Maintain knowledge of assay characteristics and performance.
• Provide scientific leadership to cross-functional teams.
• Lead generation of R&D design documents.
• Oversee validation from inception to launch, incl. sample selection and SOPs.
• Draft validation plans and summaries.
• Ensure activities meet critical path and adapt to changes.
• Assist in budgeting and cost tracking.
• Design assay performance specifications.
• Maintain compliant lab documents and procedures.
• Troubleshoot technical issues and optimize assays.
• Improve efficiency and quality of R&D efforts.
• Collaborate with tech development, bioinformatics, QA, regulatory, and the clinical lab.

Skills

Leadership

Cross-functional collaboration

Project management

Analytical thinking

Education

PhD in Nucleic Acids Biochemistry / Molecular Biology

MS in related field

Tools

NGS

PCR

qPCR

Job description

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&D

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 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.