Technical Requirements
- Good analytical hand
- Valuable management skill to handle the team members and good coordination skill with team members.
Key Responsibilities
1. Should have worked for Regulated market product development (ANDA)
2. Providing technical expertise/scientific input on formulation development strategies for ANDA / 505(b)2.
3. Preparation and practical execution of formulation development Batches using QbD concept.
4. Assisting to client during meetings with in a scientific manner.
5. Preparation of Technology Transfer documents, Development Reports Documents in eCTD format.
6. Monitoring and Execution of Scale up and Exhibit Batches (e.g. process development, implementation of new formulation techniques) and ensuring complex data are interpreted in a scientifically correct way, which can help for development of robust formulation.
7. Identifying potential stability and performance issues with prototype formulations and overcome the same.
8. Streamlining the activities associated with a wide variety of formulation technologies to shorten Formulation Lab turnaround times and improve the quality of formulations.
Qualifications
- M. Pharm/ Ph.D. - 4 - 8 yrs