Head - Formulation Development (Sterile)

Role & responsibilities

1. Leading the F&D team.

2. Literature review for product development

3. Formulation and process optimization

a) API & Excipients vendors finalization

b) RLD finalization

c) Container and closures finalization

d) Prototype formulation

e) pH extreme studies

f) pH drift studies

g) Photo stability studies

h) Bulk solution holding studies

i) Filter compatibility studies

j) Silicone tubing holding studies

k) Order of addition of API and Excipients

l) Eutectic/collapse temperature determination

m) Stability studies

4. Reference Listed Drug characterization

5. Lyophilization cycle optimization & Filter validation

6. Terminal sterilization optimization

7. Finalization of API & Excipients specification

8. Finalization of drug product specification

9. Preparation and review of documents (MFR, Stability protocols, diluents compatibility protocols, Product Development Report etc)

10. Co-ordination for analytical method transfer of API and Drug product at manufacturing site.

11. Execution of Scale-up and Exhibit batches

Preferred candidate profile

Perks and benefits