Shubham Wakde

• Formulation and Development (Ophthalmics and Injectables) for U. S, Europe and ROW market.

• Literature survey, Grade and source of APIs and Excipients selection. Indenting of Innovator samples.

• Pre-formulation studies and formulation trials leading to identifying a suitable composition for the product.

• Experiments planning in coordination with analytical team.

• Selection of mode of sterilization and filters.

• Container closure system selection and finalization.

• Results compilation and interpretation and make way forward based on results.

• Preparation of scale-up batch record and Process evaluation protocols for execution of process evaluation batches at plant level.

• Preparing of technology transfer documents for pilot/exhibit batches and commercial scale manufacture.

• Providing technical support during exhibit batches as and when required.

• Interaction with cross functional teams such as IPR, Regulatory, QA etc.

• Formulation and Development (Ophthalmics and Injectables) for U. S, Europe and ROW market.

• Literature survey, Grade and source of APIs and Excipients selection. Indenting of Innovator samples.

• Pre-formulation studies and formulation trials leading to indentifying a suitable composition for the product.

• Experiments planning in coordination with analytical team.

• Selection of mode of sterilization and filters.

• Container closure system selection and finalization.

• Results compilation and interpretation and make way forward based on results.

• Preparation of scale-up batch record and Process evaluation protocols for execution of process evaluation batches at plant level.

• Preparing of technology transfer documents for pilot/exhibit batches and commercial scale manufacture.

• Providing technical support during exhibit batches as and when required.

• Interaction with cross functional teams such as IPR, Regulatory, QA etc.

• Preparation of protocol and report of Scaleup and Exhibit batches.

• Documentation and Data management

• Sampling of products and batches.

• Handling of placebo batches and validation batches.