Title:  Executive/ Sr. Exe

M.Pharm. (Pharmaceutics) with about 7 - 10 years experience in R&D product development with injectable product development that includes liquid, lyophilized and complex injectables.

1. To have strong execution skills and to interact cross functionally and ensure timely submission and approval of the assigned projects as per agreed work plan.
2. To provide the technical value addition throughout the development to achieve timely filing
3. To conduct and review literature search and evaluate patent landscape for assigned project and work out the pathway for least time to effect successful submission.
4. To perform pre-formulation and formulation development trials using QbD approach to develop a robust formulation.
5. To manufacture batches for stability studies and analytical methods validation.
6. To involve in scale up / exhibit batches execution at plant.
7. To review Test Request reports for analysis of raw material (API / excipients) and Drug product.
8. To write Laboratory Notebook to enter the details about drug product manufacturing operation.
9. To prepare Development Study Protocol and execute the development study accordingly.
10. To prepare and review Stability protocol to charge stability batches as per the protocol.
11. To prepare and review Stability compilation sheet or development study report based on available COAs.
12. To prepare and review Technology Transfer documents like Sheet II, MF, Risk Assessment based upon CPP & CQA, FMEA.
13. To prepare Pre-IND /IND / NDA Package for regulatory communication.
14. To prepare and set the in process and finished product Specification with scientific rationale.
15. To prepare Product Development Report along with relevant back-up data for regulatory submission.
16. To prepare and review SOPs related to laboratory equipment / instrument.
17. To be a part of Equipment / Instrument Qualification activity in case of procurement of any new Equipment / Instrument and prepare and review qualification documents.
18. To ensure compliance with the internal quality system while performing any activity.
19. To timely respond FDA queries.
20. To co-ordinate with cross functional departments like ADD, RA, CQA, Plant for project / product related activity.
21. To be able to drive projects with internal and external stakeholders so as to meet the timelines.
22. Provide novel solutions to simplify product development and develop robust products.
23. To transfer projects successfully and troubleshooting if any with technical solutions so as to develop a product recipe that can be successfully manufactured post approval.