Research Scientist II

Universal Diagnostics S.A.; Dallas (TX); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

PTO 22 days

Birthday off

Insurance + life

Job summary

Universal DX, Inc. seeks a Research Scientist II to lead reagent QC method development for NGS-based IVD assays. You will design validation studies, establish reagent stability, and ensure regulatory compliance across CLSI standards.

You will collaborate with Manufacturing, QA, and Regulatory Affairs to transfer methods and documentation. Join us in advancing early cancer detection with robust QC processes.

Qualifications

• Master’s or PhD in Molecular Biology, Biochemistry, Genetics, or related field.
• 3+ years of experience developing reagent QC methods for NGS-based IVD assays.
• Familiarity with regulatory requirements (FDA, IVDR) and CLSI guidelines.
• Proven ability to design and manage validation studies.
• Excellent analytical, problem-solving and project management skills.

Responsibilities

• Reagent QC Method Development: develop/validate QC methods for reagents used in NGS-based IVD assays, ensuring accuracy and compliance.
• Reagent Stability Studies: establish in-use and long-term stability and onboard stability.
• Documentation And Reporting: draft validation protocols and reports for regulatory submissions and audits.
• Cross-Functional Collaboration: work with Manufacturing, Quality Assurance, and Regulatory Affairs.
• Process Optimization And Compliance: improve QC workflows and maintain QMS compliance.

Skills

Analytical skills

Problem-solving

Project management

Adaptability in fast-paced environment

Education

Master’s or PhD in Molecular Biology/ Biochemistry/ Genetics

Job description

About Our Company

Universal DX, Inc. is an international Company with a highly experienced team focused on cracking cancer’s code. Through our multi-omics and bioinformatics models, we have figured out how to read the disease’s signals in blood with high accuracy to detect cancer in its earliest stages. Starting with a colorectal cancer screening liquid biopsy test, we are building a multi-cancer platform that can identify the unique DNA regions associated with different types of cancers.

The Opportunity

We are seeking a highly motivated Research Scientist II specializing in Reagent QC Development to join our rapidly growing team. 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, Reagent 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”.

How You’ll Contribute

Reagent QC Method Development

• Support the development and validation of system-level QC methods for assay‑critical reagents used in next-generation sequencing (NGS)-based in vitro diagnostic (IVD) assays, ensuring accuracy, reliability, and compliance with CLSI guidelines and regulatory standards.
• Design and implement studies to support a comprehensive validation framework for reagent QC methods.
• 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 real‑world conditions.
• Partner with Data science team to 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:

• 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.
• Understanding of reagent QC method development, including functional and stability testing.
• Familiarity with regulatory requirements (e.g., FDA, IVDR) and industry standards (e.g., CLSI guidelines).
• Proven ability to design and manage validation studies.
• Excellent analytical, problem‑solving, and project management skills.
• Comfortable working in fast‑paced environment with ability to adapt to shifting priorities.

Preferred

• Experience in oncology diagnostics or liquid biopsy assays.
• Familiarity with automation systems and high‑throughput platforms.
• Prior experience transferring reagent QC methods from R&D to Manufacturing teams.

What We'll Offer

• 22 days of PTO with the possibility to carry over 10 days to the following year.
• Company Holidays, plus your Birthday off!
• Company-sponsored benefit plans, including medical, dental, and vision insurance plus life, STD, and LTD coverage, and 401(k).
• Flexible work schedule
• And more to come!

Why Now?

This is an exciting time to be at Universal DX. We are growing rapidly and starting 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.