Updated on 22 January 2013
Dr Kumar was sent to Germany where he worked in Rhein Biotech and learned the technology to make recombinant hepatitis vaccine. When he came back to India, he played a major role to setup the pilot plant in Hyderabad, bought all the required equipment, hired people, did all the pre-clinical trials for safety and efficacy in small animals. From 1994-96 he was the project manager for Hepatitis B vaccine at Transgene Biotek.
Dr Kumar, during his stint as project manager, had to deal with the various regulators in India. While recalling his experience, he says, "After putting in so much of blood and sweat for this hepatitis vaccine, I was so frustrated with the delays in the approval process that I decided to leave India for good." In 1996, he indeed left India and joined Fernz Health and Science (now Argenta) in Auckland, New Zealand. Here he headed the microbiology and the virology department. During his stint at Fernz, he was involved in developing novel assays as routine methods to quantify interferons is very laborious, which takes four-to-five days to show results.
Dr Kumar continues, "I worked at Fernz for about 2.5 years and then I joined Schering Plough, in Wellingtion. I worked in this company as a research scientist for four years in R&D department. Since this company was developing various vaccines for animals, my I had transitioned from human health to animal health. The vaccines that I worked on in Schering sere multi-valent Clostridial vaccine, Moraxella bovis vaccine, and Fusobacterium vaccine among others. I also used to provide process support to the manufacturing department as I had good understanding of fermentation and bioprocess.
After four years at Schering Plough, Dr Kumar then moved to Pfizer Global Manufacturing in Perth, Australia. He happily tells, "It was my dream to work for the biggest name in pharmaceutical industry. From my R&D role, I moved to take up the job of senior technical specialist in Pfizer, I used to work in quality assurance. I kept on taking new roles as and when the opportunity came my way. All along having worked in bioprocess, the opportunity at Pfizer gave me an insight into Fill/Finish. I worked for Pfizer for about four years and during that time contributed immensely to the site. I was responsible for the commissioning of a state-of-the-art restricted access barrier system (RABS) filling line and had a good exposure to modern blow fill seal machines for making sterile injectables.. I was also in the executive committee of Parenteral Drug Association (PDA), Australia, a body that governs injectables."
Dr Kumar then joined as a vice president in Wockhardt Biotech in 2006 December. At Wockhardt, he was responsible for quality control and quality assurance of various recombinant products such as insulin, erythropoietin, and glargine among others. "When we wanted to take our insulin to the developed markets, the guidelines were not very clear on what kind of tests should be performed to establish comparability with the innovator. We devised a strategy that included a battery of orthogonal tests and the voluminous data, which was accepted by the US FDA without a single query. During my tenure there we also completely overhauled the cold chain system by incorporating good distribution practices," says Dr Kumar.