Sharath Kumar V

Experienced with advanced scientific research methodologies and data analysis. Utilizes collaborative approach to drive research initiatives and achieve meaningful outcomes. Strong understanding of experimental design and application of innovative solutions in scientific investigations.

Study Management: Lead the bioanalytical phase for  pre-clinical and clinical studies, ensuring 100% compliance with study protocols and regulatory timelines.

In Vivo Support: Manage the bioanalysis of samples from diverse species (Rat, Mouse, NHP) for GLP-toxicokinetics (TK) and pharmacokinetics (PK).

In Vitro Assay Development: Designed and validated high-throughput in vitro assays for drug-drug interaction (DDI) and protein binding, improving turnaround time by 25%.

Regulatory Authoring: Authored in Method Validation Reports (MVR) and Bioanalytical Study Reports (BSR) for IND and NDA submissions.

Troubleshooting: Resolved matrix-effect issues in complex in vivo tissues (brain, liver)

High-Throughput Analysis: Executed routine clinical sample analysis using LC-MS/MS, maintaining a first-pass success rate of >99%..

Method Transfer: Successfully transferred  bioanalytical methods to external CROs, serving as the primary scientific point of contact.

Lab Operations: Maintained "inspection-ready" lab status through rigorous adherence to SOPs, resulting in zero major findings during a recent sponsor audit.

Sample Preparation: Expert in multiple extraction techniques including SPE, LLE, and Protein Precipitation (PPT) for both small and large molecules

Preparation of BA/BE reports-Method validations, partial method validations and study sample reports as per ICH- M10 Guidelines.

Reviewing, addressing QA and sponsor comments.

Review of Bioanalytical reports, Logbooks, Internal/External calibration certificates, etc.

Performing in-process audits during activities inside the laboratory.

Instrumentation: Proficiency in LC-MS/MS (liquid chromatography-tandem mass spectrometry), LC, and HPLC.

Sample Management: Experience in sample extraction techniques such as Protein Precipitation, Liquid-Liquid Extraction (LLE), and Solid Phase Extraction (SPE).

GLP/GMP: Strong knowledge of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).

Regulatory Guidelines: Understanding of FDA, EMA, ICH, and NMPA guidelines for bioanalytical method validation.

Technical Documentation: Proven ability to write study plans, protocols, and reports.

Data Analysis: Experience with software for data acquisition, processing, and management, including Electronic Data Capture (EDC) systems.

Troubleshooting: Ability to troubleshoot assays and analytical equipment.

Collaboration: Ability to work within a team environment.

Independence: Ability to work independently with minimal supervision.

I do hereby declare that the above information given by me is complete and true to the best of my knowledge and I bear the responsibility for the correctness of the above-mentioned particulars. Place: Bangalore

• 20/12/2018- : Participated and was a junior resource person in “One day workshop and hands on training on Basic techniques in pharmacology experiments” at PESCP, Bangalore.
• 3/4/2019- Participated “Targeted Drug Delivery – Concepts and Advances” at Dayananda sagar university college of pharmaceutical sciences. Bengaluru.
• 4/09/2019 to 5/09/2019 – Participated in the workshop “analytical techniques- A research Perspective” at KLE Academy of Higher Education, Bengaluru.
• 14/09/2019 – Participated in the one-day seminar on “Bio-printing in Life Sciences” at JSS Academy of Higher Education, mysuru.
• 18/10/2019 to 19/102019 – Participated in 6th international conference “Strategies to tackle Antimicrobial Resistance” at PES UNIVERSITY, Bengaluru.

Study Management: Lead the bioanalytical phase for  pre-clinical and clinical studies, ensuring 100% compliance with study protocols and regulatory timelines.

In Vivo Support: Manage the bioanalysis of samples from diverse species (Rat, Mouse, NHP) for GLP-toxicokinetics (TK) and pharmacokinetics (PK).

In Vitro Assay Development: Designed and validated high-throughput in vitro assays for drug-drug interaction (DDI) and protein binding, improving turnaround time by 25%.

Regulatory Authoring: Authored in Method Validation Reports (MVR) and Bioanalytical Study Reports (BSR) for IND and NDA submissions.

Troubleshooting: Resolved matrix-effect issues in complex in vivo tissues (brain, liver)

High-Throughput Analysis: Executed routine clinical sample analysis using LC-MS/MS, maintaining a first-pass success rate of >99%..

Method Transfer: Successfully transferred  bioanalytical methods to external CROs, serving as the primary scientific point of contact.

Lab Operations: Maintained "inspection-ready" lab status through rigorous adherence to SOPs, resulting in zero major findings during a recent sponsor audit.

Sample Preparation: Expert in multiple extraction techniques including SPE, LLE, and Protein Precipitation (PPT) for both small and large molecules

Preparation of BA/BE reports-Method validations, partial method validations and study sample reports as per ICH- M10 Guidelines.

Reviewing, addressing QA and sponsor comments.

Review of Bioanalytical reports, Logbooks, Internal/External calibration certificates, etc.

Performing in-process audits during activities inside the laboratory.

Instrumentation: Proficiency in LC-MS/MS (liquid chromatography-tandem mass spectrometry), LC, and HPLC.

Sample Management: Experience in sample extraction techniques such as Protein Precipitation, Liquid-Liquid Extraction (LLE), and Solid Phase Extraction (SPE).

GLP/GMP: Strong knowledge of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).

Regulatory Guidelines: Understanding of FDA, EMA, ICH, and NMPA guidelines for bioanalytical method validation.

Technical Documentation: Proven ability to write study plans, protocols, and reports.

Data Analysis: Experience with software for data acquisition, processing, and management, including Electronic Data Capture (EDC) systems.

Troubleshooting: Ability to troubleshoot assays and analytical equipment.

Collaboration: Ability to work within a team environment.

Independence: Ability to work independently with minimal supervision.

I do hereby declare that the above information given by me is complete and true to the best of my knowledge and I bear the responsibility for the correctness of the above-mentioned particulars. Place: Bangalore