Hitesh R Bhakre
Principal Scientist Formulation and Development @Glenmark Pharmaceuticals
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WORK HISTORY
Principal Scientist Formulation and Development @Glenmark Pharmaceuticals
Mumbai, IN
JOB PROFILE: Inject able Dosage form: Development of Complex Injection, Respiratory Dosage form: Inhalation Solution and Suspension Formulation and Development. Responsible for the Injectable lab and Respiratory lab set up. Support laboratory equipment maintenance, procurement and calibrations. Successfully completed scale up and registration batches of Injectable and Inhalation products at manufacturing Monroe North Carolina USA site Developing strategy for formulation and process development and the corresponding regulatory submissions Development of Feasibility report, Complexity report and COD for the Evaluation of the new products for USA market. Actively participation and contribute to deliver and engage in team discussion on issue resolution and as a representative for Formulation in CMC teams. Accountable for troubleshooting and resolving high complexity formulation challenges. Assist manufacturing operations in problem solving, investigations and corrective actions for registration and scale up batches. Drive development activities working in a cross-functional environment (IPMG, RA, ADL, QbD, DQA,PM) Review technical reports, regulatory filings, source documents, patents and external publications. Assigned product stability data management, interpretation and evaluation. Write experimental protocols, validation criteria and reports. Responsible for review of all documents related to product development like Product development report (PDR), Stability protocols, Study protocol & report, Exhibit batch protocols & report, Review of Batch manufacturing documents (MBR, BPR) for production batches, Test license, Import license API and RLD, Packaging development checklist, manufacturing license, Finished product specification, MFC and Technology transfer documents for manufacturing site.
EDUCATION
Shrimati Kishoritai Bhoyar (SKB) College of Pharmacy Kamptee Nagpur
Bachelor of Pharmacy - BPharm
Bharati Vidyapeeth
Mpharm-Pharmaceutics
ABOUT HITESH R BHAKRE
Research and Deveopment professional with 15 years of experience in formulation development for Regulated market. Successfully 6 USA products commercialized, 2 Injection (ANDA), 2 Inhalation (ANDA) and 1 Intra Nasal NDA product. Technical skills in Optimizing Formulation Development and the process for Complex Injectable dosage, Nasal dosage,Inhalation dosage, Opthalmic dosage forms. Strategic development, Planing and Documentaion as per Regualtorey market. Technology transfer for scale up batches and executes Registration batches (EBs) at Manufacturing sites, Assist Manufacturing USA site & CMO for process development of Injectables and Inhalations projects for USA facility. Successfully completion of Scale up and Registration batches on site and Received USFDA approvals. Expertise in product development using 505J, 505B2 and Optimization of Process using QBD design approach. Exposure to multidisciplinary area work involved in product development such as Intellectual property management (IP) team, Drug Regulatory (RA) team, Analytical development team, DQA, Packaging, Purchase and Project management team to coordinate them for assign projects. Expertise in handling of Solution, Suspension, Viscous products and understanding of the specific extractables and lechables.
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