Vishnuvardhan Pothugunta
Senior Scientist at Thermo Fisher Scientific
Based in Athlone, Ireland
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Seniority
Staff
Department
Research & Development
Location
Athlone
Industry
Biotechnology Research
Company size
99K
Contact information
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v•••••••@thermofisher.com
Phone
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Background
About Vishnuvardhan Pothugunta
Quality professional with over 10 years of global experience in the biopharmaceutical industry. Expertise in people management, scheduling, mentoring, and guiding teams to achieve company goals. Skilled in designing and executing method validations for complex techniques as per ICH and JP standards, ensuring timely deliverables for regulatory submissions. Adept at troubleshooting analytical methods to enhance testing procedures and conducting investigations for OOS, OOT, and deviations with effective CAPA implementation. Experienced in testing and reviewing biological products such as monoclonal antibodies (mAbs) and biosimilars for various regulatory markets. Proficient in operating and qualifying analytical instruments, including HPLC, UPLC, capillary electrophoresis, and UV spectrophotometry. Well-versed in GMP, GLP environments and maintaining quality compliance. Successfully handled regulatory audits by USFDA, EMEA, ANVISA, NPRA, and Health Canada.
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