Speaker

Umesh Kulkarni

Additional Director-Engineering/Projects, Serum Institute of India Pvt. Ltd. / Poonawalla Group

With over 25 years of experience in the pharmaceutical, biopharmaceutical, and process engineering industries, I have built my career as a Projects/Engineering professional with leading Indian and multinational organizations such as Lupin Ltd, Fosters, Dr. Reddy's Laboratories (DRL), Serum Institute of India Ltd, and FDC Ltd.

Throughout my extensive career, I have developed expertise in process engineering across various pharmaceutical and biopharmaceutical organizations. This includes solid dosages, liquid oral formulations, injectables, vaccines/biologics, ointments, powders, ophthalmic products, and more. My primary goal is to leverage this diverse experience to enhance the effectiveness of new projects and assignments.

I possess hands-on experience in the design, execution, commissioning, and validation of plants for all regulated markets. I have actively participated in and successfully navigated audits from regulatory bodies such as USFDA, MHRA, TGA, WHO, and various customer-specific audits, covering the entire spectrum from plant design to audit compliance.

My key skills and strengths lie in brownfield project management, where I have successfully overseen projects for capacity enhancement and GMP updates with minimal disruption to operations. Additionally, I excel in the management of entire plant engineering operations, ensuring the GMP state of plant, equipment, HVAC, and utilities. I bring expertise in planning, budgeting, and executing greenfield/renovation projects, including comprehensive project documentation such as concept notes, base layouts, detailed engineering, and technical evaluations of new equipment, with a focus on process evaluation and capacity balancing.

Company

Serum Institute of India Pvt. Ltd. / Poonawalla Group

Serum Institute of India Pvt. Ltd. is now the world's largest vaccine manufacturer by number of doses produced and sold globally (more than 1.5 billion doses) which includes Polio vaccine, Diphtheria, Tetanus, Pertussis, Hib, BCG, r-Hepatitis B, Measles, Mumps, Rubella as well as Pneumococcal and Covid-19 vaccines. It is estimated that about 65% of the children in the world receive at least one vaccine manufactured by Serum Institute. Vaccines manufactured by the Serum Institute are accredited by the World Health Organization, Geneva and are being used in around 170 countries across the globe in their national immunization programs, saving millions of lives throughout the world. Serum Institute of India is ranked as India's No. 1 biotechnology company, manufacturing highly specialized life saving biologicals like vaccines using cutting edge genetic and cell based technologies, antisera and other medical specialties. Serum Institute of India was founded in 1966 by Dr. Cyrus Poonawalla with the aim of manufacturing life-saving immuno-biologicals, which were in shortage in the country and imported at high prices. Thereafter, several life-saving biologicals were manufactured at prices affordable to the common man and in abundance, with the result that the country was made self-sufficient for Tetanus Anti-toxin and Anti-snake Venom serum, followed by DTP (Diphtheria, Tetanus and Pertussis) group of Vaccines and then later on MMR (Measles, Mumps and Rubella) group of vaccines. The Philanthropic philosophy of the company still not only exists but has been proliferated to bring down the prices of newer vaccines such as Hepatitis-B vaccine, Combination vaccine etc., so that not only Indian's, but the entire under-privileged children of the world are protected from birth onwards.