A company is looking for an IVD Scientist I to join their product development team focused on early cancer detection.
Key Responsibilities
Draft and review technical documents, including protocols and reports
Plan and document development and validation studies in line with regulatory standards
Coordinate study execution and analysis with lab and biostatistics teams
Required Qualifications
Ph.D. or Master's degree in Molecular Biology, Biochemistry, Genetics, or a related field
Experience with molecular biology and Next Generation Sequencing (NGS)
Knowledge of regulatory requirements (FDA, IVDR) and industry standards (CLSI guidelines)
Proficiency in the interpretation and documentation of study results
Experience with cfDNA and liquid biopsy technologies is preferred
Scientist • Hamilton, New Jersey, United States