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Senior Research Scientist
3 weeks ago
- End-to-end Formulation development of Oral solids including development, execution, filing, and approval
- Performing pre-formulation studies for material characterization, drug-excipient compatibility, and Reference Listed Drug (RLD) characterization, including reverse engineering, formulation designing, and optimization
- Coordinating closely with analytical team to devise effective Proof of Concept (POC) for developing generic equivalent of RLD generic Injections
- Supporting in scale-up to pilot plant scales for Oral solid Products
- Monitoring the development for robust, effective, and bioequivalent drug product in timely manner adhering to safety and quality standards
- Providing support in documentation for regulatory submissions
- Technology transfer and execution of the batches
- Preparing risk evaluation and risk mitigation documents, Scale-up batch documents, and filing documents for drug product at every stage of development
- Reviewing data generated and participating in discussions with experts to conclude on prototype's
