Roshan Yoganathan
Technical Operations Program Manager @Kardigan
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WORK HISTORY
Technical Operations Program Manager @Kardigan
US
EDUCATION
University of Toronto
B. App. Sci, Biomedical Engineering
UNSW
PhD, Biomedical Engineering, Chemical Engineering, Supercritical Fluids, Drug Delivery, Polymer Blends
ABOUT ROSHAN YOGANATHAN
Regulatory, Quality and Analytical Development - Combination products (device + drug product) CMC CTD section writing.*Development of QSR, ICH and cGMP compliant CFR 211.166 stability program (primary and annual), elution method, and drug product content specification setting for drug-eluting cardiac leads.* Scientific and technical expert in the use of MATERIAL CHEMISTRY and PHARMACEUTICAL SCIENCE to develop implantable/injectable/inhalable drug delivery and tissue engineering devices for oncology and regenerative medicine applications.* Developed CLASS MEDICAL DEVICES and COMBINATION PRODUCTS in the form of implantable and injectable films, gels, coatings, powder/particles and suspensions for cancer therapy.*Regulatory/Quality Courses: BLA/NDA/MAA Submissions and Commercialization by UC Berkeley Extension (UCBE), IND/CTA Enabling Studies and Agency Interfaces by UCBE, CMC Regulatory Compliance for Pharmaceutical Products by UCBE, Principles of Supply Chain and Manufacturing by UCBE, GLP by CfPA and Design Controls by AAMI.
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