Research Scientist II

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.

Responsibilities

• 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.
• 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 the Data Science team to analyze stability data and determine reagent shelf life and usage guidelines.
• Draft and review study protocols, validation reports, and other technical documentation.
• Ensure thorough and accurate record‑keeping to support regulatory submissions and audits.
• 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.
• 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

• Master’s degree or Ph.D. in Molecular Biology, Biochemistry, Genetics, or a related field.
• 3+ years of experience in developing 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 a fast‑paced environment with ability to adapt to shifting priorities.
• Preferred: Experience in oncology diagnostics or liquid biopsy assays.
• Preferred: Familiarity with automation systems and high‑throughput platforms.
• Preferred: Prior experience transferring reagent QC methods from R&D to Manufacturing teams.

Benefits

• 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.