Mentor Biography
Shyam Khante is a Pharma professional with more than 40 years rich experience in all types of dosage forms and APIs (Sterile as well as Non-Sterile). He is currently an independent consultant, and has several experts in various field associated with him in India and Overseas.
Shyam is a post-graduate in Pharmacy with a Diploma in Operations Research and Business Management. He has more than 35 years of working experience specifically in the areas of setting-up projects for world class pharmaceutical formulations / APIs, Manufacturing
He has a particular technical interest in creating world-class drug product / substance manufacturing facility(s) and very high caliber technical team(s). Employed by Foreign & Indian MNC's viz. Hoechst, Burroughs Wellcome, Parke Davis, Smithkline Beecham, GSK, Lupin and Dabur Pharma for the majority of his career. Shyam has held leadership positions with direct responsibility to Board, including international, as well as cross- and multi-functional teams.
Throughout his long and versatile career, Shyam has acquired diverse expertise ranging from Project Concept Designing, Planning, Engineering & Budgeting, Project Management, Manufacturing Management and Technical Operations, of large Projects and Facilities including special products, such as aseptically manufactured sterile, oncology products. His expertise areas include up-gradation of existing facilities of both Formulations as well as APIs, in line with regulatory guidelines, capacity and productivity enhancement, de-bottlenecking, energy efficiency optimization, balancing of utilities, Team Building, Mentoring, Motivations among others.
Some of the most notable projects led by him include containment manufacturing facility for aseptically manufactured sterile and non-sterile oral solid dosage forms Cytotoxic, anticancer products, Parenterals, R&D etc. Additionally, he has lead team of experts in preparing for the regulatory filings and GMP inspections / audits of various regulatory agencies, such as WHO, ISO, USFDA, UK-MHRA, ANVISA, ENVIMA etc.
Shyam's focus is on providing knowledge in planning / setting of pharmaceutical manufacturing facilities / technology and helping clients establish efficient and cost effective manufacturing systems, processes and teams to achieve their regulated product goals for a fast submission and seamless approval. He has a strong background in implementation of pharmaceutical manufacturing, management & quality systems. With associates and colleagues in regulatory agency and various fields / areas, such as development, engineering, supply chain, HS&E, management, human resources, regulatory affairs, Shyam brings a consolidated and comprehensive expertise for the clients.
His contribution to the Indian pharmaceutical industry has been recognized by the IDMA, IPA and EDQM by conferring him with "Best Pharmacist" award in year 2008. Considered a subject matter expert in pharmaceutical manufacturing & technology, Shyam has been a welcomed keynote speaker and presenter at many association meetings and conferences.