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Universal Diagnostics S.A. · 2 months ago

IVD Scientist I

United States

Full-time

Hybrid

New Grad, Entry Level

Universal Diagnostics S.A. is an international company focused on early cancer detection through advanced diagnostic tests. The IVD Scientist I will be responsible for planning, designing, and executing analytical validation studies for colorectal cancer screening tests, collaborating with various teams to ensure compliance with regulatory standards.

BiopharmaBiotechnologyMedical

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

Qualification

Molecular BiologyNext Generation SequencingRegulatory RequirementsCfDNA TechnologiesIVD Product ValidationCross-functional CollaborationTechnical WritingProblem-solving SkillsProject Management