Venkata Pavan Kumar Gopaluni

18 Years of Total industrial experience

Having 12 years of experience in Analytical method development and validation for the determination of Genotoxic impurities, Nitrasoamines, NDSRIsin various API Finished products using LCMSMS or GC-MS/MS.

Having 6 years of experience in the area of Bioanalytical method development, validation and biological plasma sample analysis of BA/BE studies using LC/MS/MS.

WORK EXPERINCE:

AUG’2021 – Till Now | Senior Manager-AR&D | Shilpa Pharma Life Sciences Limited , Hyderabad| Role:

• Monitoring the team for the Analytical method development and Validation for quantification of Nitrosamines, NDSRIs and Genotoxic impurities in various API Finished products using LC-MS/MS and GC-MS/MS.
• Monitoring of Non carry over studies of various Genotoxic/Nitrasoamine impurities as a part of response to regulatory queries from various agencies like USFDA, EDQM, Health Canada etc.,
• Monitoring the Documentation team for the preparation and review of Analytical Method validation Protocols, Validation data and Reports by various analytical techniques like HPLC, GC, IC,LC-MS/MS, GC-MS/MS, ICP-OES, XRPD and Particle size distribution.
• Approval of Analytical Method validation protocols, Reports, SOPs, STPs and other AR&D documents and Monitoring of Document control in AR&D.
• Monitoring of Analytical Method transfers from AR&D to QC.
• Monitoring of Implementation of GLP practices and QMS documents like Laboratory incidents, Change Controls,Document errors in AR&D activities.
• Coordinating with Quality Control and Quality Assurance team.
• Coordinating with Regulatory team for addressing the analytical related Regulatory queries

APR 2019 – AUG 2021 | Manager-AR&D | Shilpa Medicare Limited Raichur, Karnataka| Role:

• Monitoring the team for the Analytical method development and Validation of Nitrosamines, NDSRIs and Genotoxic impurities in various API Finished products using LC-MS/MS and GC-MS/MS.
• Analytical Method validation data review of Protocols, Validation data and Reports by various analytical techniques like HPLC, GC, IC,LC-MS/MS, GC-MS/MS, ICP-OES, XRPD and Particle size distribution.

APR 2015 – APR 2019 | Dy.Manager-AR&D| Shilpa Medicare Limited Raichur | Role:

• Monitoring the team for the Analytical method development and Validation of Genotoxic impurities in various API Finished products using LC-MS/MS.
• Identification of Unknown impurities observed during process optimization of various synthetic API Products.
• LC-MS/MS support for the characterization of API standards and Impurity standards.
• Review of Analytical Method validation data , Protocols and Reports by various analytical techniques like HPLC, GC, IC,LC-MS/MS, GC-MS/MS, ICP-OES, XRPD and Particle size distribution.

SEP 2011 – APR 2015 | Asst.Manager-AR&D| Shilpa Medicare Limited, Raichur | Role:

• Analytical method development and Validation of Genotoxic impurities in various API Finished products using LC-MS/MS.
• Identification of Unknown impurities observed during process optimization of various synthetic API Products.
• LC-MS/MS support for the characterization of API standards and Impurity standards and Process optimization.
• Preparation of Analytical Method validation, Protocols, reports, SOPs and STPs.
• Review of Calibration data of HPLC, GC, LC-MS/MS, GC-MS, XRPD, Particle size Analyser.

SEP 2007 – AUG 2011 | Group leader-BA/BE| Vimta Labs limited, Hyderabad | Role:

• Supervising the bioanalytical team in the areas of Bioanalytical Method development and validation using LC-MS/MS.
• Pharmacokinetic studies of NCEs in rat, mice and Rabbit plasma using LC-MS/MS.
• Toxicokinetics studies of NCEs in rat and mice using LC-MS/MS.

APR 2005 – AUG 2007 | Junior Reserach associate-BA/BE| GVK Bioscinces, Hyderabad | Role:

• Bioanalytical Method development and validation using LC-MS/MS.
• Subject sample analysis of various BA/BE studies