The Opportunity

This role will play a critical role in developing and executing quality control (QC) methods for reagents used in our NGS-based diagnostic assays. Reporting to the Director, Assay Development, this role will oversee reagent QC method development as well as establish reagent freeze/thaw (F/T) stability and onboard reagent stability to ensure robust assay performance and compliance with regulatory standards. This role will also play an integral role in coordinating the transfer of reagent QC methods and related documentation to the Reagent Manufacturing team.
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

Reagent QC Method Development
• Develop and validate system-level QC methods for assay-critical reagents used in nextgeneration sequencing (NGS)-based in vitro diagnostic (IVD) assays, ensuring accuracy, reliability, and compliance with CLSI guidelines and regulatory standards
• Partner with Quality and Regulatory Affairs (RA) to conduct reagent Failure Modes and Effects Analyses (FMEAs), identifying critical and non-critical reagents to mitigate risks and ensure assay performance
• Design and implement a comprehensive validation framework for reagent QC methods, including defining software requirements, performance criteria, and regulatory alignment.

• Optimize and scale QC workflows to enhance efficiency, reproducibility, and robustness, integrating risk-based approaches to reagent quality control.
Reagent Stability Studies
• Design and execute studies to establish the in use and long-term stability of reagents, ensuring long-term reliability
• Conduct onboard stability studies to evaluate reagent performance under simulated realworld conditions
• Analyze stability data and determine reagent shelf life and usage guidelines.
Documentation and Reporting
• Draft and review study protocols, validation reports, and other technical documentation
• Ensure thorough and accurate record-keeping to support regulatory submissions and audits.
Cross-Functional Collaboration:
• Partner with internal teams, including Manufacturing, Quality Assurance, and Regulatory Affairs, to ensure seamless integration of reagent QC strategies across the product lifecycle
• Collaborate with internal and external partners to facilitate process transfer and QC testing.
Process Optimization and Compliance
• Identify opportunities for process improvement and implement solutions to enhance
efficiency and reproducibility
• Maintain adherence to quality management systems (QMS) and regulatory compliance
throughout all QC activities.

Qualifications:

Required:

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• Master's degree or Ph.D. in Molecular Biology, Biochemistry, Genetics, or a related field.  3+ years of experience in development reagent QC methods for NGS-based IVD assays
• Strong understanding of reagent QC method development, including functional and stability
testing
• Prior experience transferring reagent QC methods from R&D to Manufacturing team
• Familiarity with regulatory requirements (e.g., FDA, IVDR) and industry standards (e.g., CLSI
guidelines)
• Proven ability to design and manage validation studies, including risk identification and mitigation
• Excellent analytical, problem-solving, and project management skills
• Comfortable working in fast-paced environment with ability to adapt to shifting priorities.
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Preferred
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• Experience in oncology diagnostics or liquid biopsy assays
• Familiarity with automation systems and high-throughput platforms.

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