AMAR SUNIL AGAWANE
Senior Executive
mumbra
Summary
An accomplished Senior Research Associate with 9+ years of experience in the pharmaceutical and healthcare industries, specializing in analytical method development, formulation and stability studies for injectables and solid dosage forms. Proficient in operating advanced analytical instruments (HPLC, GC, UV-Vis), adept at troubleshooting and ensuring regulatory compliance across diverse pharmaceutical projects. Aiming to contribute expertise in quality control, method validation and research & development.
Overview
13
13
years of professional experience
Work History
Senior Executive
Topiox Research Centre pvt ltd
11.2025 - Current
- Team Leader – ADL Department
- Supervised and guided a team, ensuring productivity and task completion
- Planned and assigned daily work, improving overall efficiency
- Tracked team performance and provided feedback for improvement
- Ensured compliance with company policies and quality standards
- Handled problem-solving and supported team members in critical situations
Senior Executive
Intas Pharmaceutical ltd
06.2025 - 11.2025
- Preparation analysis of in-process formulations, innovator samples, stability samples and raw materials
- Doing inverse engineering projects utilizing GC and HPLC techniques
- Perform diluents compatibility and formulation development studies for injectable and OSD products
- Conduct formulation development studies for injectable and OSD products and force degradation studies
- Prepare method development reports and stability sample data to support product validations
- Schedule and perform calibration of analytical instruments such as HPLC and GC
- Manage troubleshooting and maintenance of HPLC and GC, ensuring optimal lab equipment performance
- Uphold stringent laboratory practices in line with GLP standards for equipment and workspace maintenance
- Preparation of online documentation using lab and electronic lab notebooks (LIMS)
- Preparation of reports on method development, workability, and verification for finished injectable and OSD products
Senior Research Associate
Macleods Pharmaceuticals Ltd.
11.2023 - 05.2025
- Conduct analysis of in-process formulations, innovator samples, stability samples and raw materials
- Engage in reverse engineering projects utilizing GC and HPLC techniques
- Perform diluents compatibility and formulation development studies for injectable products
- Conduct formulation development studies for injectable products and force degradation studies
- Compliment method development reports and stability sample data to support product validations
- Schedule and perform calibration of analytical instruments such as HPLC and GC
- Manage troubleshooting and maintenance of HPLC and GC, ensuring optimal lab equipment performance
- Uphold stringent laboratory practices in line with GLP standards for equipment and workspace maintenance
- Maintain meticulous online documentation using lab and electronic lab notebooks (ELN)
- Generate detailed reports on method development, workability, and verification for finished injectable products
Senior Analyst
Indoco Remedies Pvt Ltd.
08.2021 - 11.2023
- Conducted analytical method validations for assays, dissolution and related substance testing to ensure compliance with industry standards
- Performed analyses on liquid and solid dosage formulations during the development phases
- Executed stability studies on RS, assay, and dissolution for development batches, aiding in quality assurance and product integrity
- Supported the Quality Control (QC) department in the analysis of stability samples to maintain consistent product quality
- Developed and finalized documentation for stability studies, process batches and batch development, enhancing data integrity and process verification
- Oversaw the calibration of critical laboratory instruments including HPLC, balances, pH meters, and dissolution testers according to established SOPs
- Reviewed, updated and initiated changes to SOPs, ensuring adherence to regulatory and internal standards
Junior Scientist
Inventia Healthcare Pvt Ltd.
02.2018 - 08.2021
- Validated analytical methods for assays, dissolution and related substance testing to ensure regulatory compliance
- Analyzed liquid and solid dosage formulations across various development stages
- Performed stability studies for RS, assay, and dissolution, contributing to product development and quality assurance
- Assisted the Quality Control (QC) team in analyzing stability samples, ensuring the accuracy and reliability of results
- Prepared and maintained detailed documentation for stability, in-process, and development batches, streamlining report generation
- Conducted reviews of stability batch data and compiled reports to support product approvals and modifications
- Oversaw the internal calibration of laboratory instruments including HPLC, balances, pH meters, and dissolution testers, maintaining alignment with standard operating procedures (SOPs)
- Reviewed and updated SOPs, and initiated change controls to meet evolving regulatory and company requirements
Analyst (ARD)
SITEC Labs Pvt Ltd
01.2016 - 01.2018
Senior Officer
Hermes Ecological Pvt. Ltd.
01.2015 - 12.2015
Officer
Omkar Specialty Chemicals Pvt. Ltd.
06.2013 - 12.2014
Education
Master of Science - Organic Chemistry
Mumbai University
Mumbai, India01.2013
Bachelor of Science - undefined
Birla College Kalyan
Kalyan, India01.2011
Skills
Key Skills:
Analytical Method Development
Research & Development
Quality Control Analysis
Stability Testing
Formulation Development
Method Validation Instrument
Calibration Data Compilation
SOP Creation & Review Project
Management Regulatory
Compliance
MS Office Proficiency AutoCAD Basics
WATERS HPLC (Empower 3, Lab Solution, Open Lab)
Agilent HPLC (Empower 3, Lab Solution, Open Lab, Chromeleon 71)
Shimadzu HPLC (Empower 3, Lab Solution, Open Lab, Chromeleon 71)
Perkin GC (Empower 3 Software)
KF Titrando (Metrohm)
Potentiometer (Metrohm)
UV-visible spectrophotometer (Shimadzu)
Densitometer
Osmometer (freezing point depression)
Dissolution Tester (Lab India, Electrolab, Sotex, Type-4 Disso)
Ion Chromatography
X-ray Diffractometer
Malvern Particle Sizer 3000
Polarimeter
Auto Titrator
Team Collaboration
Time Management
Adaptability
Organizational Skills
Communication Skills
Leadership
Data Analysis
KEY HIGHLIGHTS
- Analytical Method Development & Validation: Developed and validated analytical methods for assays and related substances following ICH guidelines
- Formulation Development: Specializing in injectables; experience in reverse engineering and force degradation studies
- Regulatory Compliance: Thorough knowledge of ICH guidelines and GLP regulatory requirements
- Project Management: Experience managing cross-functional teams for successful R&D and quality control initiatives
- Quality Control & Stability Testing: Expertise in stability studies, raw material analysis and documentation
Timeline
Senior Executive
Topiox Research Centre pvt ltd
11.2025 - Current
Senior Executive
Intas Pharmaceutical ltd
06.2025 - 11.2025
Senior Research Associate
Macleods Pharmaceuticals Ltd.
11.2023 - 05.2025
Senior Analyst
Indoco Remedies Pvt Ltd.
08.2021 - 11.2023
Junior Scientist
Inventia Healthcare Pvt Ltd.
02.2018 - 08.2021
Analyst (ARD)
SITEC Labs Pvt Ltd
01.2016 - 01.2018
Senior Officer
Hermes Ecological Pvt. Ltd.
01.2015 - 12.2015
Officer
Omkar Specialty Chemicals Pvt. Ltd.
06.2013 - 12.2014
Master of Science - Organic Chemistry
Mumbai University
Bachelor of Science - undefined
Birla College Kalyan