Rakesh Bhardwaj Email and Phone Number

Over 20+ years of experience in various fields like Human Plasma Therapeutics, Vaccines and Antisera manufacturing at various positions in QC I worked start to finish in various projects in Vaccine R&D – Analysis of clinical trail human serum samples for Diphtheria IgG, Pertussis IgG, Pertussis PT/FHA, Pertussis Pertactin, Tetanus IgG, Haemophilus Influenza type b, Hepatitis B and Anthrax) .In QC Vaccine - Quality Control tests (Biological/Microbiology / analytical testing).To carryout calibration/validation activities- HVAC, LAF, Cleaning validation, Incubators, DPB, Deep freezers, Cold rooms, and sterilizers) and a competent professional with proven abilities of managing Quality control Operations.QC and R&D Antisera - Development of test methods for Antibody fragments (anti-SARS CoV-2, antitoxins and anti-venoms), Human Blood products, and Vaccines .Broad range of experience in Biological testing , analytical techniques to conduct Drug substance and drug product characterization, method validations and stability evaluation, hold time, compatibility and comparability studies. Extensive skills in conducting process improvement, formulation development, internal and external Technology transfers and regulatory submissions and having technical skills in handling Physico-chemical analytical techniques of Antibodies, therapeutic proteins and vaccine API and Drug products testing, Small Animal based Biological potency assays (Mice and Guinea pigs) and Immunological assays (ELISA), Product Characterization: Methods for identity, purity, potency, quantification, and stability evaluation. Pharmacopeia general methods for quality control - IP BP and USP, Proteins and polysaccharides analysis methods, HPLC analysis, protein mapping, SDS- PAGE and UV spectroscopic methods.Having Exposure in facing WHO Geneva Pre-Qualification audits; Joint inspections (DCA- Telangana, CDSCO-Hyderabad, DCGI- New Delhi, CRI- Kasauli) regularly. Faced USFDA & Ukraine PICs, IMRES (Indonesia),My Strengths - Self-directed, Passionate, with comprehensive accomplishment, vaccine development, I have acquired strong research skills and knowledge to use various methods to study molecules from development stage to production stage. Also involved in successfully handling Projects and in supporting cross-functions to meet timelines. I also have lab experience with extensive knowledge of the tools and procedures used in concern testing.