Group Lead - Process R&D - API - CRDMO
ConfidentialHyderabad / Secunderabad, Telangana, India5 days ago
Job descriptionEnsure the good organization and housekeeping of the PRD department work area. Plan and supervise developmental synthesis of the NCEs / API intermediate / target molecules. Excel in the observation, recordings and reporting skill sets for the scientific data. Work as a team and take responsibility with accountability. Surveys the literature for information concerning specific compounds. The Feasibility study of custom products involves close monitoring / supervision by research associate. The Process Optimization shall be made on the selected route based on due diligence and literature during the feasibility studies. Prior to designing laboratory experiments for process optimization, the MSDS of all input materials shall be obtained and scrutinized for risk assessment. To improve processes for existing products and improve efficiency in cycle time. Ensure and sign off the experimental data related to process development studies of the NCEs / API intermediate / target molecules manufacturing are recorded in Electronic Note Book (ELN). To write process descriptions in the Technical Package and transfer optimized manufacturing strategies to production. PRD to support the technology transfer team towards the efficient scalability of a given process to the manufacturing site. To evaluate, recommend new technologies and equipment for synthesis, purification and implement their use in PRD and demonstrate the same to TT. To support the clients with respect to all the analytical and CMC needs for each project being handled by PRD. Actively participate in investigation of various complaints and quality related issues like CAPA, closing out the deviations in the manufacturing. Ensure the good organization and housekeeping of the PRD department work area. Plan and supervise developmental synthesis of the NCEs / API intermediate / target molecules. Excel in the observation, recordings and reporting skill sets for the scientific data. Work as a team and take responsibility with accountability. Surveys the literature for information concerning specific compounds. The Feasibility study of custom products involves close monitoring / supervision by research associate. The Process Optimization shall be made on the selected route based on due diligence and literature during the feasibility studies. Prior to designing laboratory experiments for process optimization, the MSDS of all input materials shall be obtained and scrutinized for risk assessment. To improve processes for existing products and improve efficiency in cycle time. Ensure and sign off the experimental data related to process development studies of the NCEs / API intermediate / target molecules manufacturing are recorded in Electronic Note Book (ELN). To write process descriptions in the Technical Package and transfer optimized manufacturing strategies to production. PRD to support the technology transfer team towards the efficient scalability of a given process to the manufacturing site. To evaluate, recommend new technologies and equipment for synthesis, purification and implement their use in PRD and demonstrate the same to TT. To support the clients with respect to all the analytical and CMC needs for each project being handled by PRD. Actively participate in investigation of various complaints and quality related issues like CAPA, closing out the deviations in the manufacturing.
Skills Required
msds, Process Optimization
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Lead • Hyderabad / Secunderabad, Telangana, India