About Rakesh Bhardwaj:
Vaccine and Antisera Manufacturing
I had put up over 18 years of experience in various Vaccine and Antisera manufacturing Plants at various positions in QC (Panacea Biotec Limited, Biological E Limited Hyderabad, VINS Bioproducts limited Hyderabad), Pharmaceutical Manufacturing (Aurobindo Pharma Limited Hyderabad, and R&D Department - (Panacea Biotec limited New Delhi)
I worked start to finish in various projects (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) (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 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 accomplishments Scientist, vaccine development, Quality testing of vaccines molecules and in various biological molecules characterization and efficacy testing. I have acquired very strong research skills and knowledge to use various methods to study vaccine molecules from development stage to production stage. Team building, training, motivation and mentoring, understanding different stages of manufacturing process , multi-disciplinary technical skills, Ability to organize & prioritize multiple tasks, understand technical data, decision making and troubleshooting skills , Facility setup, organization and maintenance, project planning, budgeting, coordination & resource allocation, internal and external communications, team management, documentation and safety and. 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 this industry.
I have good interpersonal skills and ability to work independently or as part of a research team. I adjust to changing environments quickly and have the ability to work on multiple projects efficiently. I also have excellent communication skills along with the ability to write and give presentations to explain the results of the research and to work effectively with other professionals.
I’m Passionate and committed individual looking to join a goal oriented team, and I’m very grateful if I could get an opportunity to prove myself. I can make an immediate and positive impact on the operational performance of your organization. I would welcome a personal interview to further discuss my qualifications and professional experiences
I will be obliged, if you can consider me for a suitable position.
Thanks and Regards
I did my M. Sc. (Biotechnology) from Barakatullah University, Bhopal in the year 2005, India,
B.Sc. from H.P University, Shimla in the year 2003, India
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