Research Scientist
Brawn Laboratories limited
Total years of experience :0 years, 10 Months
• Pharmaceutical Product/ Technology/Formulation Development for Generic Drugs from conceptualization to proof of concept, technology transfer for global regulatory filings and commercialization of drug products.
• Literature and patent search
• Strategic planning and co-ordination of various R&D activities
• Propose formula suitable for bio studies and provide scientific justifications
• Preparation of product development report (PDR) as per QbD format and Question based review (QbR).
• Designing of stability, hold time study, photo stability, compatibility, In-use study, Breakability study protocol as per guidelines.
• Prepared scale-up BMR & execute the batch as per approved protocol for finalization of processing parameter before exhibit batches. Based on exhibit batch data parameter proposed for intended BMR.
• Review of In-process, Released product, finished product and Stability product specification.
• Reply the query raised by regulatory bodies with justification.
• Review and finalization of technical direction, optimization protocol, optimization report, Batch size etc.
• Review of BMR, intended BMR, Batch formula and Batch summary.
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