Leader and Translational Science Director working on analytical, process validation and clinical validation of NGS automated assays for clinical diagnostic tests. Demonstrated track record in developing novel complex multiplex amplified assays which were successfully commercialized as IVD approved products. Technical group leader for multiple projects from research to development with particular strengths in a technical team environment working closely with scientists and engineers.• Directed applied research and assay development teams for gene expression assays, biomarkers in clinical samples and novel nucleic acid detection assays, including real-time RT PCR, Invader Plus (Cleavase technology plus PCR) and real-time transcription mediated amplification• Developed clinical sample processing methods with lysis protocols for bone marrow aspirates, serum, plasma, whole blood, urine and nasal swabs • Demonstrated assay performance for multiple assays that achieved the Target Product Profile performance metrics with clinical samples that were successfully developed and approved CE IVD and FDA IVD products• Expertise in IVD product focused feasibility research, technology development, assay platforms and product development under design control • Assessed technical assay , clinical performance and product viability for potential corporate acquisitions