Jignesh Doshi

Biography

Sr Manager/Scientist Company Name Serum Institute of India Limited Dates Employed Jan 1996 – Present Employment Duration 21 yrs 9 mos Location PUNE Manager Company Name Serum Institute of India Limited Dates Employed Jan 1996 – Present Employment Duration 21 yrs 9 mos  Large scale purification: Development and validation of high yield protein purification processes. Define critical attributes and generation of protocols and reports.  Development of meat free media for tetanus and diphtheria vaccines upstream as well as down stream processing.  Equipments and instruments : Designing, qualification, SOP writing and operation of production equipments viz. filtration systems (Microfiltration,Ultrafiltration systems), Chromatography systems, fermentors, heavy duty centrifuge, incubators etc. Analytical instruments: HPLC, electrophoresis instruments (IEF, PAGE, Rotaphore, Preparative electrophoresis), ELISA, Western blot, HPTLC etc.  Facility : Designing and validation of large scale production facility as per cGMP.  Process and Cleaning validation: Defining critical attributes protocol writing and report generation. Risk assessment.  Analytical methods : Immunochemical methods, biophysical and biochemical methods, Molecular biology methods, Bio-assays, Animal potency and toxicity assays, functional assays.  QA systems : Implementation, functioning and review of QA live systems Change control, OOS, CAPA, Deviation, Training, SOPs.  Formulation : Mono valent, combination and controlled release vaccine formulations  Applied biostatistics, Experimental design and Data interpretation

Research Interest

Pharmaceutical company