Deputy Manager - Formulation Development (FRD)

Role & responsibilities

1. Responsible to lead a team of 4-5 scientist for the development of drug products of Regulated Market (EU and UK)

2. Responsible for drug product development to exhibit batch execution and to support for regulatory filing.

3. Conduct Literature survey and compile the scientific data per product. Development of Rubust, bioequivalent formulation and processes through optimization by applying QbD principles.

4. Compilation and review of developmental data and exhibit batch stability data.

5. Should have good understanding on Reference Product Characterization, reverse Engineering, Bioequivalent Prototype development, Stability studies, Scale up activities.

6. Coordination with different cross functional team like ADL, IP, Project Management, SCM, Clinical and regulatory for smooth execution of the projects.

7. Execution of Tech Transfer and monitoring scale up / Exhibit batches.

8. Having well verse knowledge on Regulatory Guidelines for EU, Canada and TGA

9. Lab activities and team management experience is must.