Rebecca Ortiz Marty, PhD, LSSGB

Senior Scientist with extensive experience on In Vitro Diagnostic (IVD) product and application development with expertise in flow cytometry, immunology, and host-pathogen interactions. Over five years experience in characterization, verification, and validation of clinical applications and in-process testing for cell therapy products. Collaborative team player in multifunctional environment. Experience in composing documentation for submission to FDA. Skills: -Years of experience in meeting industry requirements for developing and releasing FDA-approved clinical flow cytometry applications adhering to CLSI guidelines. Experience in designing and developing cell therapy processes adhering to ICH Q2 (R1) guidelines. Experience working with CMO sites. Lean Six Sigma Green Belt certified. -Laboratory techniques Flow cytometry: Over 10 color panel design, execution, and analysis for immunophenotyping, cell functionality, and T-cell epitope-mapping. Cell culture, chemotaxis assays, ELISA, ELISPOT, real-time PCR, RNA and DNA isolation. -Process Improvement and trouble solving: Quality-focused problem solving during assay development to reduce variability and re-work. Scientific perspective to reducing variation during cell functional assays and improve validation of processes for industry. -GLP and GXP compliant, proficient in SOP composition. -Project management, mentoring, and multi-tasking.