Scientist 1 - Formulation Development Regulated Market (EU/UK/Canada)

Role & responsibilities

1. Literature Search, Pharmacopoeia and Patent Search, Review and Discussion and Documentation.

2. Application of NOC, Test License, Manufacturing and Import License

3. Reference product Characterization, Manufacturing and Import License.

4. Reference product Characterization, Reverse Engineering and prototype development.

5. Preformulation study, Manufacturing of bench scale trials for formulation development.

6. Manufacturing of process optimization batches, scale up batches and submission batches.

7. Preparation of Bill of Material, Master Formula Record for manufacturing of submission batches.

8. Preparation of Product development Report for regulatory filing of products.

9. Should have knowledge on product development requirements for Regulated market (EU/UK/Canada).

10. Should have knowledge on QbD and DOE, formulation development and Process development of drug products.

11. Coordination with CFTs like: DQA, Clinicals, Regulatory, Technology transfer and production for smooth development and transfer of product from laboratory to Production floor.

12. Knowledge on IR/MR solid oral drug products.

Preferred candidate profile

Male candidate only