Sanket Gawas

WORK HISTORY

EDUCATION

SKILLS

ABOUT SANKET GAWAS

I am an experienced Analytical Scientist specializing in Formulation Analytical R&D for complex injectable products, with a strong background in method development, validation, and regulatory-compliant testing.🧪 Technical Expertise• Analytical Testing: Assay, Dissolution, Related Substances, Particle Size Distribution (Mastersizer & Zetasizer), Water Content, Zeta Potential, Viscosity• Instrumentation: HPLC, GC, Mastersizer, Zetasizer, Viscometer, Karl Fischer, and other compendial techniques• Method Development & Validation: Analytical and Cleaning Method Validation as per ICH & USP compliance• Data Integrity & Documentation: Stability sample analysis, trend analysis, OOS/OOT investigations, report preparation, and cGMP documentation Key Skills & Contributions• Designing and validating robust analytical methods for injectable formulations• Compiling and interpreting stability data for regulatory submissions• Preparing and reviewing SOPs, instrument calibration protocols, and validation documents• Ensuring compliance with USP, ICH, cGMP, and GLP guidelines Professional Engagement• Delivered technical presentations and shared findings with cross-functional teams• Collaborated with formulation, quality, and regulatory teams for project alignment• Engaged with customers and internal stakeholders to address queries and provide scientific support Soft Skills• Strong problem-solving and troubleshooting abilities• Effective communicator with presentation and technical writing skills• Highly organized with excellent time management and adaptability• Collaborative mindset, committed to precision, innovation, and continuous improvement GoalTo leverage my Analytical R&D expertise and cross-functional skills in contributing to Regulatory Affairs and global drug development initiatives.