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Research and Development Professional
5 days ago
This is a key role that requires strong analytical and problem-solving skills to improve product, process, and analytical methods robustness. The ideal candidate will have a deep understanding of global regulatory expectations, project management, and knowledge of stability programs and shelf life determination processes.
Key Responsibilities- Support appropriate specifications setting.
- Improve product, process, and analytical methods robustness.
- Develop analytical methods for raw materials used in new/BVO products.
- Conduct validation of new developed analytical methods for raw materials.
- Conduct verification of available Compendia analytical methods for raw materials.
- Develop stability indicating analytical methods for new/BVO products.
- Conduct validation of newly developed analytical methods for new/BVO products.
- Conduct verification of available Compendia analytical methods for new/BVO products.
- Arrange reference standards and impurities for the development of new stability indicating analytical method.
- Support implementation of Process Analytical Technologies (PAT) to achieve real-time release.
- Conduct validation on first three commercial scale batches.
- Conduct real-time stability studies on first three commercial scale batches.
- Support in the development of artwork of packaging components.
- Lead/direct appropriate analytical method validations, transfers, and other supportive activities between development centers, sites, external suppliers, etc.
- Provide clear and timely analytical investigations of any product counterfeiting/customer complaint/contamination events supporting issue resolution with appropriate communication, escalation, and closure.
- Support in bio-equivalence/bio-availability studies of the new/BVO products.
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