A SME in Extractable & Leachable, offering 18 years of experience, post PhD, in Analytical Chemistry, MBA from IIM Indore and Certified ISO 9001 Lead Auditor with diversified knowledge on analytical product development, setting cGMP Laboratory and handling technical teams. Proven ability to investigate needs and develop analytical methods for products quickly and cost-effectively. Ability to cultivate a positive team environment on engagements and contribute to team personnel's professional development; exposure to managing a technical team of 60+ members. Analytical Expert offering inputs on method development, validation and technology transfer for product optimization, value engineering, remediation and geo- expansion. Subject Matter Expert for designing, execution and interpretation of Extractable & Leachable studies, including Genotoxic and Mutagenic Screening by using DEREK and LHASA software Directed Analytical R & D strategies and programs, including building a high- performance R&D organization, aggressive recruiting of leading scientific staff, and the overall managing of the analytical development plans for ANDA, NDA & NCEExpertise in setting an operational 100,000 ft2 state of art R&D Lab with 3500 ft2 GLP Analytical lab. I am on LinkedIn to connect with like-minded professionals to share my experience and expertise. Core Skills• Problem Solving• Project Coordination • Analytical Abilities• Setting up GMP laboratory’s • Commercial Acumen • Quality Assurance • Teamworking• Analytical Product Development • Extractable and Leachable • Influential Communication