Principal task and Responsibilities: Major Purpose of the Joke •Develop the cost effective and robust process of APIs •Coordinate the internal customers to deliver the product on time •To prepare and review the documents for regulatory and technology transfer requirements •Facilitate documentation for DMF filing and customer query •Manage a group of scientists on their work-planning as well as evaluate and uplifting their skills and job efficiency. Principal Tasks and Responsibilities: 1.Research, analytical, problem-solving and team building & management skills. 2 Literature search, evaluation, summary of literature search & finalization of ROS for non-infringing process of assigned API molecules 3 RM procurement and follow up, process development planning and execution and to fulfil all user end requirement 4 Enhancing production process operations, optimizing resource utilization, escalating productivity and efficiencies. Provide plant support to Ankleshwar team during plant validation batches and scale up batches 5. To investigate plant scale up related issues and identification of CPP/CQA and preparation of CAPA/ Investigation report 6 Process feasibility study, Process development, process optimization & process validation in accordance with regulatory requirements 7 To coordinate with cross functional departments like IPR. RA, procurement, QA and to take clearance approval from concerned departments whenever required. 8.To develop cost effective, high quality and minimum environmental hazardous process following CGMP. & GLP guidelines. 9: To prepare Process Development Report (PDR) and to prepare documents for Drug Master File (DMF) 10. To manage the smooth functioning of lab activities with team of subordinates 11. Synthesis, isolation and characterization of Pharmacopeial and process impurities & WRS preparation of FP and its intermediates. 12. Interface between various functions sach as CSBU, Regulatory, Manufacturing, R&D, QA/QC and Marketing. 13.Creating novel ideas and implement them to create IP assets (Patent filing) 14 Coordinating the activities with AR lab. Regulatory, QA and Production 15. Working efficiently on complete response on DMF-Querry of APIs giving scientific inputs and making proper scientific justifications to clear the DMF In the process, communication and working closely with R&D-Synthesis, Analytical, QA, and RA-Department.
