Summary
Overview
Work History
Education
Skills
Accomplishments
Workshops Conferences Attended
Personal Information
Timeline
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Vidya Muley

Senior scientist API at Biocon Ltd
Bangalore

Summary

Analytical Research & Development professional with 9+ years of experience specializing in GC and GC-MS analysis of synthetic, semi-synthetic, onco products, peptides, raw materials, intermediates, and APIs. Proven expertise in method development, qualification, and transfer for complex molecules, including peptides like Liraglutide and Glatiramer Acetate. Strong track record in supporting regulatory filings, resolving plant-level OOS/OOT issues, and ensuring GLP/GMP compliance.

Equipped with a deep understanding of analytical instruments including HPLC, GC, IR, UV Spectrometer, and Karl Fischer. Known for a sharp analytical mindset, problem-solving ability and a commitment to quality and timelines. Energetic, adaptable and always ready to learn, with a hands-on approach to tackling challenges and delivering results that drive organizational success.

Overview

10
10
years of professional experience
2015
2015
years of post-secondary education
4
4
Languages

Work History

Senior Scientist

Biocon Ltd
01.2021 - Current
  • Lead analysis of synthetic, semi-synthetic, onco products, peptides, raw materials, intermediates, and APIs using GC and GC-MS.
    • Supported regulatory filings for key peptide-based drugs such as Liraglutide and Glatiramer Acetate.
    • Developed and qualified GC and GC-MS methods for complex molecules, including peptides and semi-synthetic compounds, from KSM to final product stage.
    • Prepared and reviewed Standard Testing Procedures (STPs), Method Qualification Protocols (MQPs), and Method Qualification Reports (MQRs).
    • Ensured strict compliance with GLP and GMP standards across analytical activities.
    • Successfully executed method transfers of critical GC methods to manufacturing plants within defined timelines.
    • Played a key role in peptide method development and optimization, contributing to strategic R&D initiatives.
    • Conducted risk assessments to identify hazards and implemented mitigation strategies to protect lab personnel and resources.
    • Performed advanced OOS/OOT investigations for plant-related issues, delivering detailed technical reports on time.
    • Continuously learned and applied new lab techniques, contributing to improved experimental outcomes under senior guidance.

Scientist

Dr. Reddy's Laboratories
01.2019 - 01.2021
  • To perform analytical method development and method validation parameters, method transfer.
  • To prepare method validation protocol and report, method transfer protocol.
  • Preparation of Standard Operating Procedure, Standard Testing Procedure, General test procedure, Specification, COA, Stability Study Compilation, Validation and Method Development Reports etc.
  • To perform related substances, Assay, water content, Physical parameter and other quality control tests on modern analytical instruments according to GLP.
  • Analysis of API, excipients, in-process samples, finished product samples and stability study samples etc.
  • Responsible for writing laboratory notebook by recording accurate and complete experimental methods and results.

Senior Executive

Micro Labs Ltd
04.2015 - 01.2019
  • Company Overview: API R&D Centre
  • Analytical Method Development and Validation for APIs and its intermediates by HPLC and GC.
  • Provide efficient analytical support to regulatory queries for WHO, EP and USP authorities.
  • Routine Analysis for Assay, Related Substance & Content in API by HPLC and GC.
  • Provide quality, efficient and timely analytical support to CRD during process optimization in terms of analyzing the samples of API and intermediates.
  • Performing WET lab analysis by techniques such as Water content, IR, Melting point, solubility.
  • Perform instrument calibration as per calibration schedule.
  • Follow current GLP as per the established procedure.
  • API R&D Centre

Education

M. Pharm. - Pharmaceutical Chemistry

Manipal College Of Pharmaceutical Sciences

B. Pharm. - Pharmacology, Pharmaceutics, Medicinal Chemistry, Pharmaceutical Analysis

M S Ramaiah College of Pharmacy

Skills

Analytical Research and Development

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Accomplishments

  • All India Rank 119 in GPAT 2013
  • All India Rank 110 in Manipal Entrance Exam
  • All India Rank 600 in NIPER 2013
  • Qualified BITSAT 2013 for admissions to M Pharm
  • State Level Rank 3rd in Karnataka PGCET

Workshops Conferences Attended

  • Attended guest lecturers organized by college as a part of Pharmacy week celebration
  • Attended Indian Pharmaceutical Congress at Bangalore held in Dec 2011
  • Participated in organizational and cultural events conducted
  • Attended workshop on Insilico methods in Drug discovery (QSAR and Docking Studies)

Personal Information

  • Spouse's Name: Krishna Patil
  • Date of Birth: 01/26/90
  • Marital Status: Married

Timeline

Senior Scientist

Biocon Ltd
01.2021 - Current

Scientist

Dr. Reddy's Laboratories
01.2019 - 01.2021

Senior Executive

Micro Labs Ltd
04.2015 - 01.2019

B. Pharm. - Pharmacology, Pharmaceutics, Medicinal Chemistry, Pharmaceutical Analysis

M S Ramaiah College of Pharmacy

M. Pharm. - Pharmaceutical Chemistry

Manipal College Of Pharmaceutical Sciences

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Vidya MuleySenior scientist API at Biocon Ltd