About two decades of scientific leadership and management experience in Pharmaceutical Research and Development in the areas of Generics formulation (Rx and OTC), NCE and Specialty products with top most pharma majors in India and Asia. A demonstrated track record of delivery, building and scaling-up R&D organization to drive new product innovation and leading transformation initiatives to build a fit for purpose organization that can drive business priorities. Has a good understanding of business opportunities, challenges and ability to develop R&D strategy to drive top line growth. Display a intrapreneurial mindset, a clear business purpose, anticipating and creating value for all stakeholders. Inventor on 10+ patents and author/co-author of 10+ research publications in the areas of Drug Delivery, Formulation Development and Technology. About five years of experience in Overall Management of Pharmaceutical Research and Development Centre, developing products of different dosage forms. The products were developed and filed with different regulatory agencies (FDA/EU/Canada/ROW) for marketing approval. As a formulation functional expert hand on experience on development of following categories of complex generic formulation with Para IV certification for ANDA &505B-2 applications.a. Sterile Products: Lyophilized Dry powder, Liquid monophasic injections, Emulsion, Liposomal and colloidal dispersion based injectable formulation., Ophthalmic and Otic suspension for ANDA and 505 B-2 Applicationb. Solid orals: Immediate release, Delayed release, Extended release and modified release for ANDA/505 B-2 Application (Tablet, Capsules and suspensions) (Oncology as well general solids)c. Solid Orals: Investigational products of Antibacterial category for NDA application, Technology driven projects for 505B-2 applicationI am an enthusiastic, self-motivated, hands-on, results-driven researcher, inventor and manager who continuously demonstrates a high level of commitment and business acumen. I am also a strong team leader who will exert every effort to ensure that the goals of the team and organizations are met. I am quick to adapt to new environments and research techniques and technologies
Listed skills include Formulation, Pharmaceutics, Pharmaceutical Industry, Leadership, and 7 others.