Biosketch

• Around 22 years of experience in Analytical department at various levels, worked in the regulatory environment throughout the career.

• Developed and validated analytical methods for various drug substances, drug products, Excipients, Foods, Dietary supplements, Inter mediates and Raw materials under various Instrumental techniques like HPLC, GC, LCMS, GCMS, IC, ICP-MS. Hands on experience in Impurity isolations/purifications by using Preparative HPLC & SFC.

• Possess rich & qualitative experience in Reference standard laboratory (Qualification of reference standards) and in Quality control, handling of regulatory queries, and involved in several regulatory and overseas customer audits.

• Successfully set up a new Analytical laboratory at Daicel Chiral Technologies-India.  

• Successfully coordinated and part of the core team which set up a new quality department at United States Pharmacopeia in the year 2006. 

• Excellent knowledge in Project Management skills, working as a project manager for different projects.

• Successfully coordinated for achieving NABL Accredited ISO 17025:2005 & ISO 17025:2017 certification.

• Experience in laboratory setup as per the GLP and Safety requirements. 

• Delivered courses on USP General chapters at various workshops & Symposiums.  

• Guided more than 25 MS Pharma students , guided 2 Ph. D students and 5 Ph.D. students work is in progress.

• More than 45 publications (as Author and Co-Author) in both International and National journals.