Kevin Shah

Background

About Kevin Shah

I am a results-oriented Vaccine Technologist specializing in Upstream process development, focusing on developing recombinant vaccines. My goal is to contribute to the advancement of the vaccine industry. In my current role as Operations Specialist in Merck’s Viral Antigen Group, I support my supervisor in overseeing the manufacturing of Renogen and Forte V for aquaculture. My role involves assisting with production oversight, ensuring compliance with cGMP and safety protocols, coordinating quality assurance processes, and supporting process optimization. I leverage my expertise in biologics manufacturing, cell culture, and virus production to enhance efficiency, drive continuous improvement, and contribute to high-quality vaccine production. Previously, I worked on the Upstream process development of the Novavax Covid-19 candidate at a scale using single-use technology. This role provided me with in-depth knowledge of continuous centrifugation (KSep) and depth filtration, enhancing my skills in optimizing processes and integrating new technologies. I have extensive experience working in clean room environments, adhering to regulatory guidelines, including EHS practices, 5S, and 3Rs to prevent contamination. I have a proven track record in quality management system (QMS) documentation for regulatory authorities such as Health Canada, MHRA, and the Drug Controller of India. I have worked on approved vaccines like Covishield (AstraZeneca) and Covovax (Novavax). My expertise includes engineering and designing development processes for recombinant products from bacteria and yeast, coordinating equipment qualification, and developing GMP-based facilities, providing a holistic view of GMP-based vaccine manufacturing. Key Skills and Expertise a)Proficient in handling manual and automated systems, including Bioengineering bioreactors. b)Expertise in optimizing and scaling up vaccine manufacturing processes using recombinant bacteria and yeast. c)Experienced in clean room environments, adhering to regulatory guidelines, and conducting aseptic operations without contamination failures. d) Skilled in managing teams, overseeing a team of over six individuals, assigning tasks, and defining roles and responsibilities. e)Efficient in handling documentation activities, preparing process validation protocols, and working with cross-functional teams, including QA and QC, to meet regulatory requirements for new product development.