Rajiv Modha

I am a result-oriented pharmaceutical/biotech leader with over 37 years’ track record for driving operational efficiency, consistency, quality and regulatory compliance in drug development and commercial operations, with experience of leading and managing (i) manufacturing and supply chain function of commercial and R&D products, (ii) transfer of manufacturing process and methods, (iii) quality control, analytical R & D, quality assurance, quality systems (change control, CAPA, deviations, OOS, investigations), (iv) facility qualification, qualification of manufacturing and packaging equipment, process validation, computer systems validation, method validation, cleaning/hold-time validation, shipping validation, serialization of commercially distributed products, (v) conducting audits, managing international regulatory inspections, and (vi) authoring CMC filings for biologics drug substance and drug product, API’s, tablets, capsules, liposomal formulations, lyophilized products (small molecules and biologics, BLA, NDA, ANDA); worked at small and large pharmaceuticals as well as service-oriented organizations such as CRO, CMO and consulting firm. Worked in Europe, Canada, and USA. Familiar with GMP (CFR 21 Part 210, 211, 600), ICH Q, CFR 21 Part 11 and DEA regulations. Have worked with organizations with on-site manufacturing and testing as well as virtual organizations