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WHY CV
WHY -My Research
WHY Summary
DSP/USP/Technology Transfer/Process Development/Analytical/Applied Biology
Vaccines; APIs; Bio-similar/Enzymes; Bio-fuel; Probiotics; Food products; Phyto-compounds.
Typhoid polysaccharide, Pneumococcal polysaccharide, Polysaccharide conjugate vaccine, CRM
cGMP/GDP/GLP/R&D/EHS/ QMS/IPQA/Auditing-process/R&D/QRM/QBD/DoE
Applied Biology Professional with 16+ years of Research and Industrial Experience evolved with a comprehensive Interdisciplinary approach.
My strength is my adaptability, either as a ‘Team member’ or as leading the team; I am successful in balancing the leadership accountability and personal accountability.
One of my recent major achievements is development of typhoid conjugate vaccine (Launched on 17th Feb 2020: THYPHIBEV); I played a major role in the process development from lab scale to commercial scale.
Another achievement was successful in getting grants from research funding agencies and active players in new discoveries.
Products developed and handled for Technology transfer: Typhoid polysaccharide; Typhoid conjugate vaccines; Pneumococcal polysaccharide; Carrier protein –CRM197.
Well-equipped technical experience to drive & lead the projects effectively and interaction with regulatory agencies (real time experience with WHO, GSK & NRA).
Focused and demonstrated ability in bio-process and manufacturing skills for generation of value added quality products (PoC, Commercial and Technology Transfer projects, Clinical manufacturing/QBD/DoE).
Experience in handling and working with multiple products related to bio-pharmaceuticals and biotechnology.
Experience in SAT/FAT and equipment manufacturer (Vendor) auditing in perspective of process equipment.
QMS /QRM experience dealing with OOS/OOT/Deviations/Change controls/RoR/PV protocol/CV protocol/IPQA and Internal auditing of quality and process.
Good work Experience in R&D, Start-up, Pilot and Manufacturing level industries dealing with the following applied Biological Products Like- Vaccines, Bio-similar, API, Molecular Biomaterials, Probiotics (bacteria), Fungi, Enzymes, Biofuels, Floriculture, Plant based products etc., (Biological E Ltd, Designer Energy, Shri GBS Biotech Pvt Ltd, AVT Biotech);
Proven success in working with different projects (Pneumonia, Typhoid, Paratyphoid, CRM, Industrial Enzymes), where I was responsible for process development, clinical manufacturing, scale up, validation, support for NRA registration. Experience working with bacteria (isolation/Strain improvement/stock cultures/cell banking) and fungi (growth/sporulation etc.,) from lab scale, pilot scale (10L) to 2500 L process scale to manufacture the conjugate Vaccines. Adept with greenfield and brownfield biotechnology projects (commissioning/qualification/execution), project management, program management and techno commercial negotiation
Auditing- Internal auditing experience, Process validation; Analytical quality Assessment, EHS
Bio-Processing- Fermentation Biology- Molecular Biology, Purification of Biomolecules, QBD/DoE
Bio catalytic Technologies
Biotechnology Industry establishment, GMP/cGMP/GLP/GDP/EHS, QMS etc.,
Biomass and Biofuel; Algal fuel
cGMP: experience in cGMP and current on going vaccine technology
Doctoral Degree-Ph. D, in Applied Biology (Microbiology)
Enzyme & Food based products Production Technology; Animal feed technology; Aqua Feed; Animal probiotics,
Failure Mode analyis-FMEA:Experience in Risk and failure mode analysis for any green and grey bio-projects
GXP: GMP GLP GDP GWP: all Good practices where ever applicable can be analyzed, implemented, auditable and good experience in handling all GXP related activities at any manufcaturing or reseach sites.
Lab to Commercialization process technology development,
Molecular Cloning and Expression, purification of proteins and bio-chemical and structural characterization,
Novel Ideas for commercial products,
Polysaccharide Vaccines:Polysaccharide conjugate vaccines-Typhoid-Pneumo-Paratyphoid-Shigella-Niseeria-etc.,
Quality Management: Six Sigma/Quality Assurance/Risk management/Technical Support for Marketing the Scientific Instruments and Bio-tech products,
Research: Doctoral Research, Post-doctoral research, R&D/DoE
Safety: EHS Coordination, Safety activities and awareness camps; Identified best EHS member for two years.
Supply Chain Management- Cold (WHO Certified),
Technology Transfer: Pilot scale/Manufacturing Sciences/MSAT
Vaccines: Polysaccharide Conjugated Vaccines (Up & Down Stream process, Conjugation process; Analytical Research), Viral