Pharmaceutical professional with career experience in a variety of responsibilities & territories for managing international business development, licensing, sourcing & supply chain & operations with roles supporting generic development, quality affairs, manufacturing, supply chain, tech transfer & regulatory co-ordination.
Highlights
Key focus since 2002 was into the development of Nicotine & Nicotine products and commercialization, including
API development supervision including extraction from tobacco to Nicotine USP and subsequent conversion to Nicotine Polacrilex USP and ensuring completion of the US Drug Master File from the partner site, executing demand planning and supply chain co-ordination
Managed the development, scale up and commercializing of Nicotine gums & its supply chain, project plan and implementation of API supply chain from the manufacturing site
Handled development of flavors and formulations of the above, and in organoleptic survey for consumer acceptance; developing the marketing & communication strategy for the product, and in managing the marketing agents
Managed the prototype development team for Nicotine Gum, Lozenges and Mini Lozenges for international markets, in managing the initial development of CTD for the EU, including co-ordination of drafting of a BE protocol.
Coordination with Technologists/ external consultant for development of directly compressible chewing gum product, which was then transferred to a manufacturing facility for scale up and commercialization
As head of the manufacturing facility, supervised operations including manufacturing of directly compressible gum products for the medicated range, principally Nicotine and also developed prototypes of several other potential products for clients
Key role in licensing out an own development Nicotine product to a Pharma Major, coordinating 2 successful EDQM regulatory audits. and driving customer approvals for CMO business
Managed to successfully transfer process and development of key intermediates for synthetic Nicotine in India and setting up the supply base for the future
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