API Manufacturing Science & Technology expert
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24 yrs of experience in API manufacturing science and technology.
A keen strategist with over 22+ years of experience in Process Research & Development in
Pharmaceutical Industry for APIS and HPAI (Oncology). Currently, designated as a Associate Director with Cipla Ltd., Pune & Leading a team of 20. Adept in synthetic organic chemistry with expertise in design of non-infringing, cost effective, simplified process, scalable and safe synthetic route in line with QbD.
Identifying & Implementation of PAT in process operations. Development of a process in a continuous mode. Generating standard scientific documents related to pre and post-product development phases.
Driven process robustness, cost reduction projects and OOS/OOT & yield deviation investigation of commercialised HRM & LRM products. Product development at CROs. Review and response to queries from various regulatory authorities.
Practicing and implementing GLP, GMP and SHE policies. Excellent
Project management & ability to collaborate with cross-functional teams.
MSc (Organic Chemistry) + Ph.D.