Universal Diagnostics S.A.
Universal DX, Inc. is an international company focused on cracking cancer’s code through multi-omics and bioinformatics models. By reading disease signals in blood with high accuracy, we detect cancer in its earliest stages. We have built a liquid biopsy test for colorectal cancer and are expanding into a multi-cancer platform that identifies unique DNA regions associated with different cancers.
We are seeking an experienced Senior Scientist to join our growing product development team. In this role you will help design, develop, and commercialize next‑generation sequencing (NGS) assays/products for early cancer detection and will lead the execution of performance studies for our colorectal cancer screening test.
How You’ll Contribute
Draft and review technical documents, including protocols, reports, and 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 contribute innovative solutions. Partner with Automation, R&D, QA, 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. What You’ll Bring
Required Training/Experience Master’s degree or PhD in Molecular Biology, Biochemistry, Genetics, or a related field (preferred). 5+ years of prior experience designing and developing in‑vitro diagnostic (IVD) products with a focus on NGS products, or an equivalent combination of education, training, and 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, with data‑driven decision making. Strong project management abilities. Flexibility and independence in work execution. Organized, thorough, and detail‑oriented. Excellent communication, teamwork, and proactive problem‑solving. Professional English writing and speaking skills are required. Why Now?
This is an exciting time at Universal DX. We are rapidly growing, expanding our U.S. operations, building new labs and business functions, and establishing strategic partnerships. Passionate changemakers are invited to join our journey. What We’ll Offer
22 days of PTO with carry‑over of 10 days into the following year. Company holidays, plus your birthday off. Company‑sponsored benefit plans, including medical, dental, vision, life, STD, LTD, and 401(k). Flexible work schedule. Relocation support for the DFW area for on‑site roles.
#J-18808-Ljbffr
Draft and review technical documents, including protocols, reports, and 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 contribute innovative solutions. Partner with Automation, R&D, QA, 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. What You’ll Bring
Required Training/Experience Master’s degree or PhD in Molecular Biology, Biochemistry, Genetics, or a related field (preferred). 5+ years of prior experience designing and developing in‑vitro diagnostic (IVD) products with a focus on NGS products, or an equivalent combination of education, training, and 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, with data‑driven decision making. Strong project management abilities. Flexibility and independence in work execution. Organized, thorough, and detail‑oriented. Excellent communication, teamwork, and proactive problem‑solving. Professional English writing and speaking skills are required. Why Now?
This is an exciting time at Universal DX. We are rapidly growing, expanding our U.S. operations, building new labs and business functions, and establishing strategic partnerships. Passionate changemakers are invited to join our journey. What We’ll Offer
22 days of PTO with carry‑over of 10 days into the following year. Company holidays, plus your birthday off. Company‑sponsored benefit plans, including medical, dental, vision, life, STD, LTD, and 401(k). Flexible work schedule. Relocation support for the DFW area for on‑site roles.
#J-18808-Ljbffr