Manasi Bavkar

Currently working as a Senior Research Associate having 4+ years of experience with knowledge of problem solving and analytical skills while working on various projects along with different technical skills along with data interpretation and troubleshooting. Strong teamwork, passionate, result oriented high on integrity & execution.

Senior Research Associate at Microlabs Limited (2024-06 – Present)

• Conducted method feasibility studies for APIs and Excipients, evaluating chromatographic conditions and system performance.
• Performed API working standard qualification and routine analysis using HPLC, GC and LC-MS including assay, Residual solvent and system suitability evaluation.
• Protocol-based method development using HPLC and GC.
• Coordinated and supported stability studies of pharmaceutical formulations conducted at an external/other manufacturing plant.
• Supported formulation validation activities including protocol preparation, execution, and documentation review.
• Performed particle size analysis using Laser Diffraction technique (e.g., Malvern Mastersizer) for pharmaceutical raw materials and finished products, to ensure compliance with specifications and regulatory requirements.
• Carried out microscopy analysis using Optical Microscope to evaluate particle morphology, shape, and surface characteristics. Examination for identification of foreign particles and material characterization.
• Knowledge about nitrosamine impurities.
• Interpreted analytical data and prepared accurate, review-ready reports for QC and validation activities.

Research Associate at Unichem Laboratories Limited (2021-11 – 2024-05)

• Method development and mini-validation for carry-over and query samples.
• Reaction monitoring synthesis process by HPLC.
• Instrument calibration, qualification, and troubleshooting.
• GMP documentation preparation and review (SOPs, STPs, specifications, validation protocols).
• Regulatory audit support (US FDA, MHRA, Internal CQA).
• Regulatory report preparation and data review.
• Hands-on experience in method development and analysis using HPLC, UPLC, and IC techniques.
• Wet chemistry analysis for APIs including assay, LOD, pH, and titration as per pharmacopeial methods.

Master in Pharmacy in Quality Assurance – Savitribai Phule Pune University (2019 – 2021)

Bachelor in Pharmacy in Pharmacy – Mumbai University (2015 – 2019)