Senior Scientist

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.

Universal DX is seeking an experienced Senior Scientist to join our growing product development team working on the development and commercialization of Next Generation Sequencing (NGS) assays/products for early cancer detection. This role will work cross-functionally in the planning, design, and execution of development studies characterizing the performance of the 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 cancers. As part of the team, you will be in a Company that aims more than to become one of the leaders in the industry. We want to have a huge positive impact on society by achieving the ambitious purpose of “making cancer a curable disease by detecting it earlier”.

• Draft and review technical documents, including protocols, reports, and standard operating procedures (SOPs).
• Plan and document development studies in alignment with regulatory standards.
• Coordinate the execution and analysis of studies with the lab and biostatistics teams.
• Identify and address technical challenges in assay workflow and help provide innovative solutions.
• Partner with Automation, R&D, Quality Assurance, and Regulatory Affairs teams to meet project deadlines.
• Contribute to cross‑functional meetings, presenting progress and technical insights.
• Maintain adherence to quality management systems (QMS) and ensure compliance with regulatory guidelines.
• Draft and/or contribute to key DHF documents and support risk management activities.
• Provide technical expertise and leadership in assay development.
• Mentor and provide guidance to junior team members.

Required Training/Experience

• Master’s degree or PhD in Molecular Biology, Biochemistry, Genetics, or a related field is preferred.
• 5+ years of previous experience in the design and development of in vitro diagnostic (IVD) products with a focus on NGS products, OR an equivalent combination of education, training, and/or experience.
• Proven ability to design and manage product development studies, including risk identification and mitigation.

Recommended Training/Experience

• Familiarity with regulatory requirements (e.g., FDA, IVDR) and industry standards (e.g., CLSI guidelines).
• Detail‑oriented, self‑motivated, and able to work independently in a fast paced, dynamic environment.
• Excellent track‑record of collaboration with multiple functional areas.
• Preference for experience with liquid biopsy/cfDNA assays.
• Familiarity with automation systems and high‑throughput platforms.

Personal Skills

• Excellent analytical and problem‑solving skills, and the ability to make data driven decisions.
• Excellent project management skills.
• Flexibility.
• Ability to work independently and proactively without supervision.
• Organized and thorough with attention to detail.
• Excellent communication, teamwork, self‑driven, proactive, and problem‑solving skills.
• Professional English writing & speaking skills are a must.

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.

• 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
• Relocation support to the DFW area for on‑site roles.
• And more to come