Job Title: Principal Scientist - DPD
Purpose of Job
To lead (2-3 projects) and execute various drug product development studies for those projects. To build a strong process and formulation development related expertise in the group. To prepare stability protocols, compile data, prepare trend analysis and stability reports for a given project.
Skill Required
Formulation development, DP process development, Global filing and scientifically addressing regulatory queries, Analytical skills (HPLC and CE)
Roles and Responsibilites
1. | Preparation of scientific justifications for regulatory queries for various markets |
2. | Prepare and/or review protocols and reports for various activities including formulation and stability |
3. | To conduct pre-formulation studies and formulation development |
4. | To conduct Technology transfer and support in process validation batches |
5. | Response to QA observations and closure of reports |
6. | Preparing and updating of SOP’s. Ensuring the calibration & PV of the equipment as per the schedules |
7. | Ensure completion of the work as per the project timelines and priorities |
8. | Take up additional lab responsibilities such as instrument maintenance |
9. | Review of LNBs, Raw data and study report to ensure integrity |
10. | To bring in more scientific depth to studies conducted and reports written |
11. | Any other responsibility assigned by the supervisor |
12. | Stability data evaluation and trend analysis for various projects |
13. | Working as department training coordinator for activities related to training management. |
Competencies
Qualification Required
M Pharma and PhD
8-12 years of Industry experience
Relevant skills / Industry experience
8-12 years of Industry experience in formulation department
Relevant professional / Educational background
M Pharma & Phd
Any other requirements (If any)
Compensation / Reward
Biotech, Ahmedabad, GJ, IN, 382213