Vts Sai Kumar

About Vts Sai Kumar

Skilled in handling Digital PCR(dPCR) assays, HCP ELISA, HCDNA by RT PCR, Residual protein A ELISA, Capillary electrophoresis, Electrophoretic methods, Mycoplasma by PCR, BSA by ELISA, Moisture content estimation by KF method, Neomycin estimation by RP-HPLC method), Virus titration assays CCID50, Virus Identity, Haemadsorption, Adventitious virus testing. Preparation, review and approval of method transfer protocol/ report, method validation protocol/report and execution of these activities as per the project requirements.Handling of quality management systems like OOS/OOT/Laboratory Incident/Deviation/CAPA and change controls through TRACKWISE application. Work with Cross functional teams for timely closure of QMS tools.Reporting and investigation of Incidents, Deviations, OOS & OOT. Preparation and review of Standard operating procedures, Specifications and Standard testing procedures in DMS application software.Involved in trend preparations with respect to OOS and OOT in the lab.Involved in quarterly and annual trend preparations with respect to Internal controls used in various testing.Review and approval of data entered in LIMS application software for release of batches.Review of usage log books and Laboratory control records including electronic and audit trails of instruments.Involved in the Brownfield project with respect to lab expansion.

Experience

1. Manager

   Biological E. Limited

   Nov 2021 — Present · Hyderabad, IN

   Planning In-process, finished product and Stability samples testing of viral vaccine products and reporting of results in defined timelines for Physiochemical, Molecular Biology and Instrumentation based testing methods (Mycoplasma by PCR, BSA by ELISA, Quantification of process related impurities like residual host cell DNA (Hc-DNA), Host cell proteins(HCP), Moisture content estimation by KF method, Neomycin estimation by RP-HPLC method).Handling Virus titration assays CCID50, Virus Identity, Haemadsorption, Adventitious virus testing.Handling Quality management system like OOS/OOT/Laboratory Incident/Deviation/CAPA and change controls through TRACKWISE application. Work with Cross functional teams for timely closure of QMS tools.Preparation, review and approval of method transfer protocol/ report, method validation protocol/report and execution of these activities as per the project requirements.Reporting and investigation of Incidents, Deviations, OOS & OOT. Preparation and review of Standard operating procedures, Specifications and Standard testing procedures in DMS application software.Involved in trend preparations with respect to OOS and OOT in the lab.Involved in quarterly and annual trend preparations with respect to Internal controls used in various testing.Review and approval of data entered in LIMS application software for release of batches.To coordinate with the team for completion of assays as per TAT for batch releases.Review of usage log books and Laboratory control records including electronic and audit trails of instruments.Involved in Brownfield project with respect to lab expansion.Identification of training requirements within the team and ensure for timely completion.

Education

• Jawaharlal Nehru Technological University

  Master's degree(Part Time), Biotechnology

  2010 — 2013