Nihal Bharadwaj
R&D Executive | Process Development | Bioprocess Engineer-Downstream | Protein Purification | Manufacturing Specialist | PhD Aspirant (Immunology & Infectious Diseases)
- Role
- Executive R & d (Downstream) Vaccines at Biological E. Limited
- Location
- Hyderabad, IN
- LinkedIn followers
- 500 followers
About Nihal Bharadwaj
Mr.Nihal Bharadwaj is a biotech professional with over 2 years of specialized experience in biologics, focusing on downstream processing (DSP) for biosimilar manufacturing and vaccine development.(His expertise in process development and bulk purification)-+Research and Development of Recombinant Polyoma Virus-Like Particles (VLPs) based vaccine development.+ Purification of Pneumococcal Polysaccharides bulk.+Insulin Glargine and its analogues for large-scale biosimilar drug substance (DS) manufacturing.+In addition his DSP experience, he has worked in sterile drug product (DP) manufacturing, particularly within Fill Finish operations. Key achievements include-+Managing large-scale vial and cartridge line production for sterile drug products.+Ensuring compliance with cGMP standards and regulatory frameworks.+Implementing process optimizations to enhance efficiency and ensure high product quality.Additional expertise-+Strong proficiency in cGMP compliance and regulatory adherence.+Media formulations, sterile cell culture and bioreactor operations.+Hands-on experience with analytical methods and molecular biology techniques.
Experience
Executive R & d (Downstream) Vaccines
May 2024 — Present · Hyderabad, IN
Research and Process development for the purification of recombinant Polyoma Virus-Like Particles (VLPs) expressed in insect cells lines (SF9) in development of Polyoma VLPs Vaccine.Dissembly, Reassembly, Viral Inactivation,Viral Clearance, Bulk purification, In-Process Analysis.+Advancements in the Pneumococcal Polysaccharide (PssA) bulk antigen purification process focus on enhancing purification efficiency and product consistency in commercialization.+I bring a strong technical acumen in a range of industrial purification systems and techniques, coupled with hands-on experience in cGMP compliance.Industrial SkillsPurification Systems: Proficient in operating HPLC, MPLC, FPLC, LPLC, AKTA Pure 150, Unicorn Software,AKTA Avant, DAC Columns, Axichrom BCG Columns, and Hi-scale columns.Chromatography Techniques: Expertise in Ion Exchange, Reverse Phase, Size Exclusion, and Hydrophobic Interaction Chromatography (HIC).Filtration Techniques: Skilled in tangential flow filtration (TFF), depth filtration, Ultrafiltration (UF), Diafiltration (DF) and lyophilization.Analytical Techniques:SDS-PAGE, Agarose gel electrophoresis, protein estimation (BCA and Bradford) bioassays, western blotting, gel electrophoresis, and spectrophotometry.Quality and Compliance:Experience with formulation, validation processes, quality management systems (QMS).
Education
Central Board of Secondary Education
Junior High/Intermediate/Middle School Education
1998 — 2013
Sam Higginbottom University of Agriculture, Technology And Sciences (SHUATS)
Bachelor of Technology - BTech
2015 — 2020
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