Manoj Kumar has more than 15years of experience in upstream processing, media /buffer preparations, Commissioning & validations. He has actively involved in product development, scale up and commercial scale manufacturing of bulk drug substances of vaccines including recombinant vaccines, polysaccharide, conjugate vaccines & conventional vaccines. He has extensive experience of bacterial and yeast upstream/fermentation.
He is well versed with Quality risk management, Establishment/implementation of QMS in existing and upcoming manufacturing units, Validations (Process, cleaning, system and equipment).
He is an Operations Professional with good knowledge of Large scale manufacturing of Bulk drug substance with expertise on upstream processing i.e., Fermentation. He is M.Sc. (Biotechnology) with 15+ years of experience in the field of Fermentation, Validations, Support functions and handling of Quality Management system in vaccine industry. He has expertise in Media preparation, Buffer preparation and reagents for production of Recombinant Hepatitis B vaccine (Pichiapastoris based platform).
He has expertise in operations of upstream processing area (Fermentation) for Recombinant Hepatitis B vaccine (Pichiapastoris based platform). He is well versed with Quality risk management, Establishment/implementation of QMS in existing and upcoming manufacturing units, Validations (Process, cleaning, system and equipment).