Lead R&D Scientist, Assay Development & Validation

Jobtailor; Chicago (IL); On-site; USD 110,000 - 170,000; Full time

Job summary

Jobtailor in Chicago, IL seeks a scientifically skilled leader to guide cross‑functional teams in assay development and FDA‑regulated IVD projects. You will own design document generation, validation planning, and timely delivery to meet milestones.

Responsibilities include leading validation activities, ensuring workflow SOPs, and maintaining compliant lab records while driving continuous improvement in RD efficiency and quality.

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 with nucleic acid technologies, preferably NGS, PCR, and qPCR.

Responsibilities

• 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 align with project critical path and adapt 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.

Skills

Assay Characteristics Knowledge

R&D Design Document Management

Laboratory Validation

Workflow And SOP Development

Assay Performance SpecificationsDesign

Technical Issue Troubleshooting

Project Budget Tracking

Job description

Jobtailor in Chicago, IL seeks a scientifically skilled leader to guide cross‑functional teams in assay development and FDA‑regulated IVD projects. You will own design document generation, validation planning, and timely delivery to meet milestones.

Responsibilities include leading validation activities, ensuring workflow SOPs, and maintaining compliant lab records while driving continuous improvement in RD efficiency and quality.