Description

Principal task and Responsibilities: Major Purpose of the Job: 1. Responsible to deliver API (by non-infringing route for DMF) in cost effective manner in a time bound fashion and as per marketing requirements as agreed in UID. 2. Responsible for the Transfer of the technology from lab scale to plant scale for DMF filing. 3. Responsible to address query responses and provide related supporting experimental data to regulatory department to address the queries received from regulatory body. 4. Responsible to review the PDR, product characterization, specification and BMR in compliance with regulatory requirements. 5. Responsible for the co-ordination with cross functional department to meet assigned tasks and targeted timelines activities. Principal Tasks and Responsibilities: 1. Literature search by Sci-Finder and evaluation, summary of literature search and finalization of ROS base on cheaper and commercially available raw materials. 2. Check and define the feasibility of proposed ROS, design the experiments and optimization of process. 3.



Responsible to resolve any issues/queries related to other departments such as QA, RA, Analytical, PE and Plant w.r.t. product process, scale-up, technology transfer, risk assessment, investigation of any failure, etc. 4. Evaluation of GTI and N-nitroso impurities in drug substance. 5. To develop cost cffective process meeting regulatory quality and minimum environmenta! hazardous process by following cGMP & GLP guidelnes. 6. Provide support o the subordinates to achieve the goal by using lechnical knowledge and experience. 7. Characterization of working standards of KSM, intermediates and finished products and impurity standard by using PXRD, 1H NMR, 13C NMR, IR, Mass, DSC, TGA and ICP-MS techniques. 8. Create novel ideas and inplement them to create IP assets after discussion with IPR team and superior. (Patent filling) 9. Preparation of technical package for customers and process development report (PDR) and reviewed the documents. 10. Training and development of the team members.

📌 Senior Manager (Dholka)
🏢 Cadila Pharmaceuticals
📍 Dholka