Accomplished Senior Analytical Scientist with a proven track record at Off Targets Research Private Limited, specializing in analytical method development and validation across various formulations. Expert in HPLC systems operation and maintenance, coupled with a robust understanding of USFDA guidelines and GMP practices. Demonstrates exceptional problem-solving abilities and a commitment to enhancing analytical accuracy and efficiency.
Overview
8
8
years of professional experience
Work History
Senior Analytical Scientist
Off Targets Research Private Limited
01.2023 - Current
Method development activities: Analytical method development of related substances, assay, and preservative content methods for different dosage formulations (injectable, ophthalmic and solid oral dosage formulation).
Executed method validation for analytical methods for different dosage formulations (Injectable, Ophthalmic and solid oral dosage formulation).
Analysis of stability samples at different time periods, compilation of stability data.
Calibration of HPLC, Dissolution, Analytical balance and pH meter.
Involved in method transfer to manufacture site.
Trouble shooting the problems associated with instruments and methods.
Protocol & Report Preparation: Plan, write, execute and document Development and reports.
Preparation of working standard and test standards.
Involved in CSV Activities in HPLC Instrument.
Accomplished Senior Analytical Scientist with a proven track record at Off Targets Research Private Limited, specializing in analytical method development and validation across various formulations. Expert in HPLC systems operation and maintenance, coupled with a robust understanding of USFDA guidelines and GMP practices. Demonstrates exceptional problem-solving abilities and a commitment to enhancing analytical accuracy and efficiency.
Sr. Executive
Syngene International Limited
10.2022 - 03.2023
Sr. Executive
Tenshi kaizen Pvt Ltd
01.2021 - 10.2022
Executive
Shilpa Medicare Ltd
08.2017 - 01.2021
Education
M.Pharma -
Bharathi College of Pharmacy
01.2017
B.Pharma -
Bharathi College of Pharmacy
01.2015
Skills
Knowledge about validation parameters as per US FDA guidelines
Operation, maintenance, and troubleshooting of HPLC systems
Preparation and interpretation of final study reports
Hands-on experience and a thorough understanding of various analytical instruments, ie, HPLC/UHPLC (Agilent, ThermoDionex (Ultimate 3000)), UV-Visible spectrophotometer (Perkin Elmer and Shimadzu), osmometer, pH meter, particle size analyzer, Zetasizer, Malvern rheometer, and viscosity
Well-versed in various software and databases like Chromeleon, Rheocalc T, UV-Probe, UV Winlab, and Infionic software, etc
Good understanding of various regulatory guidelines, like ICH guidelines, etc
Good awareness of various GMP and GLP practices in the analytical lab
Associate
ASSOCIATE at AuthBridge Research Services Private Limited, Authbridge Research and Services pvt ltdAssociate
ASSOCIATE at AuthBridge Research Services Private Limited, Authbridge Research and Services pvt ltd