CFD Research Corporation is seeking an In Vitro Diagnostics Scientist/Engineer to design and develop diagnostic assays and workflows. The position requires expertise in various diagnostic platforms and collaboration across multiple teams to optimize assay performance
Job Summary
The role involves designing and optimizing diverse in vitro diagnostic assays across immunoassay, molecular, and biosensor platforms.
Candidates will lead the development of inline sample preparation workflows specifically for whole blood-to-plasma purification.
The position requires applying design of experiments and statistical analysis to systematically improve assay sensitivity, specificity, precision, and accuracy.
Matching Summary
Match Score: 85
CFD Research Corporation is seeking an In Vitro Diagnostics Scientist/Engineer to design and develop diagnostic assays and workflows. The position requires expertise in various diagnostic platforms and collaboration across multiple teams to optimize assay performance.
Skills & Requirements
Must-have
In vitro diagnostic assay development
Immunoassay and molecular platform expertise
Inline sample preparation workflow design
Analytical method optimization and DOE
Antibody and reagent characterization
Cross-functional design transfer collaboration
Nice-to-have
Competitive IVD landscape monitoring
FDA regulatory guidance engagement
Emerging detection technology tracking
Root cause analysis leadership
Key Requirements
Experience with ELISA, lateral flow, PCR, or isothermal amplification
Background in antibody selection and characterization
Proficiency in Design of Experiments (DOE) methodologies
Knowledge of FDA and international regulatory guidance