KVD SUBRAMANYAM .M
Hyderabad
Summary
Senior Analytical Research Scientist with over 13 years of extensive experience in analytical method development, validation, and regulatory compliance within the pharmaceutical industry. Expertise in leading cross-functional teams, improving laboratory efficiency, and ensuring data accuracy through advanced analytical techniques (HPLC, GC, LC-MS, etc.). Demonstrated leadership in solving complex scientific challenges, driving innovation, and supporting API development projects to meet international standards (GMP, GLP).
Overview
13
13
years of professional experience
1
1
Certification
Work History
Analytical Scientist
Dr.Reddy's Laboratories Limited.
06.2022 - Current
- Improved Robust analytical methods by developing RM, intermediates & Final API using HPLC, GC
- Developed custom analytical methods tailored to specific client needs, resulting in increased customer satisfaction and repeat business
- Preparation & review of MDR/MVR/Cleaning validations
- Preparation & review of Specifications/SOPS/COAS
- Managed multiple projects concurrently while maintaining strict deadlines, ensuring timely completion of all assigned tasks
- Cutoff studies of intermediates & Final API by HPLC, GC
- Qualitative and quantitative analysis by GCMS
Scientist
TCG Life Sciences
06.2020 - 06.2022
- Developed and validated analytical methods for small molecules using HPLC, improving output for R&D
- Supported cross-functional teams through wet analysis (LOD, ROI, water content), improving production accuracy
- Played a key role in troubleshooting analytical issues, leading to enhanced experimental results
Associate Scientist
Syngene
01.2018 - 01.2020
- Optimized API analysis efficiency by 20% through method development and validations by HPLC, GC
- Conducted stability studies for API compounds using PXRD, HPLC, GC, KF, supporting long-term product stability
- Supporting wet analysis (ROI, LOD, SOR, KF)
- Conducted internal audits for Regulatory compliance
- Preparation of Method development/validation reports
Associate Scientist
Dr. Reddy's Laboratories
08.2016 - 01.2018
- Improved regulatory compliance by 15% through method development, gap analysis, and impurity qualification
- Played a vital role in responding to regulatory queries, addressing scientific challenges
- Handled deficiency queries from Regulatory compliance and supported gap analysis
Research Chemist
Laurus Labs
03.2012 - 08.2016
- Conducted polymorphic studies and supported PR&D analysis, contributing to accurate assay and purity testing by PXRD, DSC, TGA
- Used advanced analytical techniques to support decision-making for complex projects
- Qualitative and quantitative analysis of API by using PXRD, DSC, TGA
- Supporting wet analysis like ROI, LOD, Water content
Education
M.Sc. - Analytical Chemistry
Aditya PG College
01.2009
B.Sc. - MPC
SCIM Govt Degree College
01.2006
Skills
- Method Development & Validation
- HPLC
- GC
- GC-MS
- Impurity Profiling
- Stability Studies
- Preparation and review of development/ validation/ verification/ Cleaning validation reports
- Advanced Instrumentation
- FTIR
- PXRD
- DSC
- FT-IR
- TGA
- KF
- IC
- Preparation & review of Specification/SOPS/COAS/ATRS
- Computer System Validation (CSV)
- Regulatory Compliance
- GMP
- GLP
- Data Integrity
- 21 CFR Part 11 Compliance
- Process Optimization
- Troubleshooting
Certification
Computer system validation
Accomplishments
- Collaborated with team of 4 in the development of Rain therapeutics and Mirati therapeutics
- Supported and successfully delivered online Projects of AMGEN
- Developed and validated Genotoxic impurities in Atorvastatin
- Developed and validated Benzene content by GCMS
- Supported to PRD for pregablin through Enzymatic process.
- Successfully submitted to china market of Dapagliflozin amorphous stability studies
Languages
English
Telugu
Hindi
Tamil
Personal Information
- Date of Birth: 09/29/89
- Nationality: Indian
- Marital Status: Married
Timeline
Analytical Scientist
Dr.Reddy's Laboratories Limited.
06.2022 - Current
Scientist
TCG Life Sciences
06.2020 - 06.2022
Associate Scientist
Syngene
01.2018 - 01.2020
Associate Scientist
Dr. Reddy's Laboratories
08.2016 - 01.2018
Research Chemist
Laurus Labs
03.2012 - 08.2016
B.Sc. - MPC
SCIM Govt Degree College
M.Sc. - Analytical Chemistry
Aditya PG College
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