Highlights:Manager (M2) / Senior Research Scientist • Extensive experience in Process Development, Characterization & Validation for the production of Monoclonal Antibodies (Bio-Similars) and Therapeutic proteins in Mammalian Cell Culture and Microbial platform

Skills:Mammalian Cell Culture, Process Development, Monoclonal Antibodies, Scale up & Tech Transfer, Manufacturing Technical Services, cGMP Operations

Manager (M2) / Senior Research Scientist 04/2021 - current
Lupin Limited, Pune, India
Industry: Pharma
Being a part of manufacturing support team for developing a scale down model (SDM) for pegylated cytokine production process trailed by the process characterization, process validation at 100 L manufacturing facility followed by the Continued Process Verification (CPV). Part of the team for the CTD writing for the BLA submission to FDA. Writing responses to queries and faced cGMP audit from the same regulatory organizations.
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Manager (M1) / Research Scientist 07/2016 - 03/2021
Lupin Limited, Pune, India
Industry: Pharma
• Being a part of manufacturing support team for developing a SDM for a Fc-fusion protein production process trailed by the process characterization, process validation at 1000 L manufacturing facility followed by CPV. Part of the team for the CTD writing for the regulatory submission to EMA, PMDA, TFDA & MCAZ. Writing responses to queries and faced cGMP audit from the same regulatory organizations.
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Assistant Manager 07/2014 - 12/2014
Dr. Reddy's Laboratories, Hyderabad, Telangana India
Industry: Biopharmaceuticals
Assistant Manager, Manufacturing Technical Services: Upstream, Biologics Division, Dr. Reddy’s Laboratories, India
Being a part of manufacturing support team responsible for monitoring, troubleshooting and implementing continuous improvements in commercial manufacturing processes. Being a part of cross functional team efforts during a technology transfer campaigns from development to commercial manufacturing plant.--
Scientist 07/2012 - 07/2014
Dr. Reddy’s Laboratories, Hyderabad, Telangana India
Industry: Biopharmaceutical
Scientist, Process Development – Mammalian Cell Culture, Biologics Division, Dr. Reddy’s Laboratories, India
Process development for the production of monoclonal antibodies (biosimilar) in mammalian cell culture. Successfully developed fed-batch cell culture processes for 2 monoclonal antibodies (biosimilar) in R&D scale and transferred to the pilot scale (300 L) for pre-clinical trials, meeting the predefined quality and productivity benchmarks. Conducted cell culture experiments, analyzed and interpreted results from process development and manufacturing operations to provide direction for optimal process development. Being a part of cell culture process development team for improving the productivity including media, feed strategies and process optimization. Improved the cell culture harvest titer without compromising the product quality requirements.--
Associate Scientist 03/2009 - 07/2012
Dr. Reddy’s Laboratories, Hyderabad, Telangana India
Industry: Biopharmaceuticals
Associate Scientist, Process Tech Transfer & Validation – Cell Culture, Biologics Division, Dr. Reddy’s Laboratories, India
Conducting process R&D experiments at laboratory and pilot scales for process optimization, characterization, scale up and technology transfer. Performed bioreactor design characterization and assessments for the transfer of cell culture process to a new facility (300 L), with geometrically dissimilar bioreactors for achieving performance equivalence in terms of quality and titers. Led an investigation on the product quality variability observed in a commercial manufacturing process and identified the root cause and implemented corrective actions for the smooth manufacturing operations. Manage and coordinate GMP campaigns for producing drug material for the pre-clinical and clinical studies.--
Technical Trainee 06/2008 - 03/2009
Dr. Reddy’s Laboratories, Hyderabad, Telangana India
Industry: Biopharmaceutical
Technical Trainee, Biologics Division, Dr. Reddy’s Laboratories, India
Process characterization of bio-pharmaceutical products entering into commercial manufacturing. Using central composite response surface method (generated by JMP software) to develop an experimental design for development of a fed-batch strategy to optimize process parameters for enhancing the antibody production from a rCHO cell line. Studying different types of ELISA for understanding monoclonal antibodies efficacy & quantitative estimation.--

Tamil Nadu Dr. M.G.R. Medical University 06/1997 - 06/2003
, , United States
Degree: Bachelor's Degree
Major:Dental Surgery
Bachelor of Dental Surgery

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