IVD Scientist I
About The Position
Universal DX is seeking a Scientist I to join our growing product development team working on the development and commercialization of Next Generation Sequencing (NGS) products for early cancer detection. Reporting to a Senior Scientist in the Product Development team, this role will be instrumental in the planning, design, and execution of analytical validation studies to characterize the performance of 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 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".
Requirements
- Ph.D. or Master's degree in Molecular Biology, Biochemistry, Genetics, or a related field.
- Experience with molecular biology and NGS.
- Proven ability to collaborate effectively with cross-functional teams.
- Proficiency in the interpretation, analysis, and documentation of study results.
- Strong writing skills and experience with documentation.
- Knowledge of regulatory requirements (FDA, IVDR) and industry standards (CLSI guidelines).
- Excellent problem-solving, analytical, and project management skills.
- Comfortable working in fast-paced environment with ability to adapt to shifting priorities.
Nice To Haves
- Experience with cfDNA and liquid biopsy technologies.
- Hands-on experience with verification and validation of IVD products.
Responsibilities
- Draft and review technical documents, including protocols, reports, and standard operating procedures (SOPs).
- Plan and document development and V&V 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.
- Collaborate with R&D teams to translate research findings into scalable diagnostic assay.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Industry
Miscellaneous Manufacturing
Education Level
Ph.D. or professional degree
Number of Employees
11-50 employees
