Ramkumar M

Accomplished Bioanalytical Scientist with over 10 years of robust experience specializing in LC-MS/MS method development, validation, and sample analysis. Proven track record executing complex preclinical and clinical studies across small molecules and biologics in compliance with global regulatory frameworks (EMA, USFDA, ICH M10). Adept at troubleshooting advanced instrumentation, managing data integration via LIMS, and leading cross-functional teams to maintain impeccable laboratory data integrity.

Senior Scientist - SYNGENE INTERNATIONAL LTD - Bangalore, India

(2021-10)

• Act as project leader for bioanalytical method development, validation, and sample analysis of various pharmaceuticals extracted from biological matrices using SPE, LLE, and PPT techniques.
• Ensure stringent compliance with GDP, GLP, GCP, and ICH M10 guidelines; actively author protocols, Standard Test Procedures (STPs), SOPs, and final study summary reports for regulatory submissions.
• Independently operate, maintain, and troubleshoot state-of-the-art LC-MS/MS platforms (Sciex Triple Quad 6500+/4500/4000, Xevo-TQ-XS/TQS).
• Manage accurate recording of raw data in laboratory records; perform rigorous peer review of worksheets, raw data, and instrument calibration schedules.
• Trained junior scientists and interns on laboratory techniques, safety protocols, and compliance standards, fostering a high-performance team culture.
• Successfully participated in internal, client-led, and regulatory GLP audits.

Senior Executive - AIZANT DRUG RESEARCH SOLUTIONS PVT LTD - Hyderabad, India

(2021-01 - 2021-10)

Served as project in-charge managing LC-MS/MS method development and validation in strict adherence to EMA, USFDA, ANVISA, and WHO standards.

• Managed critical inventory, working/reference standard storage parameters, and ensured laboratory safety guidelines were consistently met.
• Spearheaded instrument calibration schedules and coordinated documented preventative maintenance programs.

Scientist - I - NAVITAS LIFE SCIENCES PVT LTD - Bangalore, India

(2017-06 - 2021-01)

• Conducted sample analysis and literature surveys for target molecules to accelerate customized assay development timelines.
• Calibrated high-precision laboratory equipment including HPLC systems, nitrogen evaporators, centrifuges, and analytical balances.
• Awarded "GEM - Going Extra Miles" as the Best Performer of the Year (2018-2019) for driving exceptional project results under tight timelines.

Research Associate - QUEST LIFE SCIENCES PVT LTD - Chennai, India

(2014-12 - 2016-04)

• Executed routine bioanalysis and bioequivalence sample processing on Waters, Sciex, and Thermo systems for diverse regulatory submissions.
• Formulated core documentation baselines including initial STP development and data verification matrices.

Master of Science (M.Sc.) - Biotechnology - SRM University (2011 - 2013)

Bachelor of Science (B.Sc.) - Biotechnology - SRM University (2007 - 2011)