Pritesh Jain

Biography

Formulation Scientist Company Name Sanofi Dates Employed Jul 2016 – Present Employment Duration 1 yr 3 mos Location India Formulation Scientist Company Name Teva Pharmaceuticals Dates Employed Mar 2013 – Jul 2016 Employment Duration 3 yrs 5 mos Location Ambernath, Mumbai $Distinguishing Prior arts with Claims for Patent Infringement analysis for Development of Non infringing Formulation (Para IV) strategy which can be successfully commercialized. $Preparation of development strategy with identification of potential risk and critical issues related to product development.  *Literature & Patent analysis for USFDA & EMEA submission, *Innovator characterization, *Preformulation: Drug- Excipient Compatibility & Stability studies, *Development of stable and bioequivalent formulation, *Stability management, *Process optimization, *Technology transfer and Trouble shooting $Execution of Developmental Trial batches, Stability cum Bio batch (in view of drug product with least RS & desired Dissolution profile in Multimedia); Scale up batches. $Development of Discriminatory & Bio-Relavant dissolution media for IVIVC to waive N numbers of costly Bio-Availability/ Bio-Equivalence (BA/BE) studies. $Process Development & Optimization for TechTransfer with developed Design Space through Quality Risk Management (QRM). $Execution of Pivotal scale Exhibit batches & Commercial Validation batches at Mfg. Plant. $Accurate & Precise in Documentation & its review: - PDR (Product Development Report), MFC (Master Formula Card), MMD (Master Manufacturing Docket) for BMR & BPR, Process Validation, Stability (ICH-Quality) & Bio-study (ICH-Efficacy) protocols for USFDA & EMEA Regulatory submission. $Assessment of FDA Queries.

Research Interest

Pharmaceutical Science