Job Description
Role & responsibilities
1. Responsible for development of robust formulation and process to deliver high quality products within the specified timelines by utilizing available resources in best manner.
2. Responsible for characterization, lab scale development, scale-up, technology transfer and scale-up operations to manufacture the finished drug products.
3. Conducting day-to-day execution of R&D development trials, achieving desired critical quality attributes and manufacturing the stability batches and bioequivalent batches.
4. Preparing and reviewing the summary report of IP review of the new molecule to bypass the innovator patents for NCE-1, Para-IV and 505b2 filing.
5. Responsible for Literature search, patent search, Pre-formulation studies and preparing the literature review presentation of selected new molecules.
6. Applying QbD principles as an integral part of formulation development as per FDA/ICH guidelines.
7. Analyzing and reporting the data accurately in a clear and concise manner: suggesting conclusions and recommendations.
8. Reviewing and closing of final prototype formulation, which is closet in behavior to the innovator drug.
9. Preparing product review presentations of the formulation development.
10. Procurement of raw materials, packaging materials and innovator product from different vendors for selected finalized projects.
11. New product development planning for global markets (China/EU/US/WHO).
12. Giving SOP training and external training to all departmental employees and adhering to the health and safety polices, keeping the lab and laboratory equipment clean
13. Responsible for review of Lab note books, product development report and protocols (Stability/Hold time study etc.) and manufacturing records (Maser formula card, Master packing card etc.)
14. Coordinating with cross functional teams for smooth execution of projects to meet project timelines
15. Drafting QTPP for the selected products and formulation strategies to achieve target attributes
Preferred Male candidate OSD profile :
Department: Formulation and Development
Education Qualification: M. Pharm.
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