Assistant Manager - Formulations Research and Development - OSD

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/Brazil ).

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

16. Co-ordinating with customer and CRO for bioequivalence sample shipment document preparation, arranging the Bioequivalence samples, shipment and getting the return information from CRO or customer for delivery of Bioequivalence sample.

17. For In-House products, arranging of the study synopsis, review of synopsis, requesting and review of study protocols, Bioequivalence sample shipment document preparation, arranging the Bioequivalence samples, shipment and getting the return information from CRO for delivery of Bioequivalence samples.

18. Monitoring and reviewing of the In-House product Bioequivalence results and arranging the required document from CRO for regulatory submission.

Preferred candidate profile

The preferred candidate should be a male professional with OSD experience and a strong oncology background, as this would be a good fit for our requirements.