The Opportunity

Reporting to the Director of Assay Developmentthis role will be instrumental in the planning, design, and execution of analytical validation studies to establish the analytical performance of Universal DX's screening test for colorectal cancer.
You will be part of a team that is passionate about developing novel diagnostic tests for the early detection of cancer. As part of the team, you will be in a Company that aims to have a huge positive impact on society by achieving the ambitious purpose of "making cancer a curable disease by detecting it earlier".

Why Now?

This is an exciting time to be at Universal DX. We are growing rapidly and scaling our US operations by building up our team, starting our lab and business operations, and establishing strategic partnerships. We are looking for passionate changemakers to be a part of our journey in this expansive time for us.

How you'll contribute

Assay Development

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• Collaborate with R&D teams to translate research findings into a viable prototype for development
• Identify and address technical challenges in developing automated NGS assay workflows and work
cross-functionally to identify and implement solutions
• Optimize the performance of NGS-based IVD assay(s) and deliver verification-ready assay(s)
Assay Validation
• Plan, design, and execute assay verification and validation studies in accordance with CLSI guidelines
and regulatory standards (e.g., FDA, IVDR)
• Define analytical performance metrics, including limit of detection, accuracy, precision, sensitivity, and
specificity
• Ensure documentation and reporting of validation activities per regulatory requirements.
Cross-Functional Collaboration
• Partner with internal and external stakeholders, including Automation, R&D, Quality Assurance, and
Regulatory Affairs teams to meet project milestones.

Documentation and Compliance

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• Draft and review essential technical documents, including validation protocols, risk assessments, and
standard operating procedures (SOPs)
• Maintain adherence to quality management systems (QMS) and ensure compliance with regulatory
guidelines.

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Mentorship and Leadership

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• Provide technical guidance and mentorship to junior scientists and other team members
• Lead and contribute to cross-functional meetings, presenting progress and technical insights.

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Qualifications:

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• Ph.D. or Master's degree in Molecular Biology, Biochemistry, Genetics, or a related field.  5+ years of experience in IVD assay development and validation
• Strong expertise in molecular diagnostics, including NGS assays and liquid biopsy technologies
• Hands-on experience with verification and validation of IVD products
• Knowledge of regulatory requirements (FDA, IVDR) and industry standards (CLSI guidelines). Prior
experience with the FDA pre-submission process is a strong plus
• Proven ability to design and manage validation studies, including risk identification and mitigation
• Excellent problem-solving, analytical, and project management skills
• Comfortable working in fast-paced environment with ability to adapt to shifting priorities.

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Preferred Qualifications:

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• Familiarity with NGS automation systems and high-throughput platforms
• Track record of regulatory approval and commercialization of NGS-based IVD assays.

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