Hitesh Prakash Inamdar

Results-driven professional specializing in team leadership and operational efficiency. Demonstrated success in strategic planning and process optimization, leading to significant productivity improvements. Expertise in fostering collaboration and delivering high-quality results through effective problem-solving and decision-making.

• Regulatory Expertise: Successfully responded to a regulatory query within 4 days, identifying and quantifying an unspecified impurity.
• Method Development: Developed a single analytical method for 17 impurities in controlled drug substance products.
• Combination Drug Products: Led analytical method development for combination drug products containing at least two components.
• Chiral Method Development: Designed and executed chiral method development for a combination drug product at Cyprus (Europe) client site, completing method development, transfer, and pre-validation within 15 days.
• Sample Extraction Excellence: Achieved efficient sample extraction across Sustained-release, Modified-release, and Extended-release drug products, completing extraction within five trials.
• Regulatory Submissions & Approvals: Contributed to 75 regulatory submissions, securing 60 approvals.
• Advanced Analytical Methods: Developed 100+ analytical methods using HPLC, UPLC, and LC-MS/MS, all of which successfully passed validation without requiring modifications.
• FDA Compliance: Successfully completed Q1/Q2 activities for multiple products, ensuring full FDA compliance.
• Project Execution & Timeliness: Delivered all analytical activities within project timelines, ensuring zero delays due to analytical processes.
• Digital Innovation: Led the successful implementation of Electronic Lab Notebook across the Analytical Development Validation team.

• Paper presentation in International conference on 'Nano Technology and Drug Discovery on Enhancing curcumin content in turmeric by various plant cell culture.' (Plant biotechnology).
• Master’s Thesis: Isolation and Identification of bioactive compound by Supercritical Fluid Extraction and chromatography.
• Doctorial thesis is on 'To develop and validate analytical method for the estimation of some antidiabetic drugs.'

• Date of Birth: 09/15/84
• Place of Birth: Tezpur

• HPLC
• Waters Alliance
• Waters Arc (with Empower software)
• Shimadzu LC-2030C
• Agilent 1200 (with Chromeleon software)
• Shimadzu LC-2010HT (with LC Solution and Lab Solution software)
• UPLC
• Waters (with Empower software)
• HPLC with QDA detector
• UV Spectrophotometer
• PerkinElmer (UV probe)
• Shimadzu (UV-1700 Pharmaspec)
• Analytikjena (SPECORD 210)
• Dissolution Apparatus (USP Type I, II and III)
• Lab India
• Electrolab
• Sotax
• Agilent
• Varian
• Particle Sizer
• Malvern Mastersizer 2000 (Malvern)
• Malvern Mastersizer 3000 (Malvern)
• Auto titrator (Karl Fischer)
• Metrohm (Tiamo)
• Labindia
• FTIR Spectrophotometer
• Perkin Elmer

My team has been honored with the 'Team of the Quarter' award twice, recognizing our dedication and outstanding performance. We have successfully implemented e-LNB across the entire R&D domain, driving innovation and efficiency. Moreover, every project I have been a part of has been commercially viable, significantly contributing to the company's revenue growth

• Successfully completed Leadership Skills Program at IIM-A, enhancing strategic thinking, decision-making, and team management abilities.