MITTAL Bhadiyadra

Plan and conducts product development activities, including pre-formulation, formulation, process development and scale up studies, document all study details and results in laboratory notebooks and batch record compliant with cGDP and cGMP for IND, NDA and ANDA projects. Support Risk based and quality by design approach by using different models like Ishikawa diagram, 5Y method, FMEA and risk ranking. Draft risk assessment reports. Support clinical activities such as manufacturing and providing clinical supplies, draft pharmacy manuals and needed documents for IND projects. Perform physical and chemical characterization in liaison with analytical teams. Draft development study reports and technical reports summarizing product development results, discussion and conclusions. Provide support for risk-based and Quality by Design related activities during pharmaceutical development. Plans and executes cGMP pilot and pivotal/submission batches, including drafting of protocols, master batch records and reports. Authors regulatory submission documents for Investigational New Drug Applications (INDs)/New Drug Applications (NDAs)/Abbreviated New Drug Applications (ANDAs), supplements, annual reports and IR/CRL responses, covering pharmaceutical development and manufacture, including product development reports. Collaborates with Quality Assurance (QA) on investigations, Corrective Action Preventive Action (CAPAs) and Change Controls to ensure timely closure. Map out project from design selection of appropriate device to approval for drug device combination product. Support activities for development of quality system as per drug device combination product requirement. Design and implement various activities to facilitate global submission of products, collaborate with SMEs from different areas to address quarries/deficiencies from non-US regulatory agencies for approval. Preparation of regulatory documents required for NCE submissions. Support activities related to clinical trials for NCE.

Independently design, plan, and lead complex product development programs, including pre-formulation, formulation, process development, and scale-up studies, ensuring scientifically sound and phase-appropriate strategies, ensuring compliance with cGDP and cGMP for IND, NDA and ANDA projects.

Plan and conduct Pre-formulation, formulation and process development activities as well as scale-up trials for oral solids as well as liquid ANDA and NDA projects. Plan and execute studies to address patient complaints for the commercial products. Plan and conduct studies, draft responses to address CRL and DRL on the filed products. Support Risk based and quality by design approach by using different models like Ishikawa diagram, 5Y method, FMEA and risk ranking. Draft risk assessment reports. Troubleshoots formulation issues that occur during product development and scale-ups. evaluate product testing results and provide next steps for continued development. Perform of analysis of the drug product like Particle size measurement, Viscosity, dissolution, disintegration testing. To analyze and interpret results of pre-formulation studies, modifying inactive ingredients used in drug formulations, assisting in creation of final medical product, and evaluating the product's safety and efficacy. Draft protocols, reports for development studies as well as for GMP studies. Author batch records, protocols and Standard operating procedures (SOPs), product development reports and Quality Overall Summary (QOS) for ANDA and NDA. Interpretation of analytical/bio-study results. Knowledge on basic concepts of IVIVC correlations and bio relevant media selection. Perform statistical analysis to evaluate the analytical and stability results. Support filing of the current USA commercial products in other regulated markets China, Europe, Canada. Perform gap analysis, plan and execute additional studies needed to support the global projects considering requirements for the different countries. Draft documents like Product development report, 3.2.P sections to support the filling of the product to other regulatory agencies.

Led the Development of formulations and/or processes for oral solid dosage forms involving pre-formulation assessment, formulation development as well as formulation optimization to provide desired quality ofproduct by using Quality by Design (QbD) principles. Write batch records, protocols and Standard operating procedures (SOPs), product development reports for Abbreviated New Drug Applications (ANDAs). Review Product Development Notebooks. Review of relevant scientific literatures, patent literature survey and database. Managing Formulation lab. Training new Chemists and Scientist on different analytical techniques to support Formulation Development. Troubleshoots formulation issues that occur during product development and scale-ups. evaluate product testing results and provide next steps for continued development. To analyze and interpret analytical results from development studies.

Develop formulations and/or processes for oral solid dosage forms involving pre-formulation assessment, formulation development as well as formulation optimization to provide desired quality of product by using Quality by Design (QbD) principles. Conducting laboratory scale studies, manufacture pilot scales and scale up batches as needed. Perform dissolution testing and other analytical testing required during product development using laboratory equipment and record in the laboratory notebooks. Analyze and interpret data from formulation development to perform additional experimentation as needed. Write batch records, protocols and Standard operating procedures (SOPs). Remain current in the field by review of relevant scientific literatures, patent literature survey and database.