Formulation Development(Injectables)

Formulation Development Scientist Sterile Liquid Dosage Forms and Lyophilized Products

Key Responsibilities:

1. Formulation Development & Optimization: Lead the development and optimization of sterile liquid dosage forms and lyophilized products, including scale-up and pilot batch manufacturing.
2. Stability Studies & Protocol Design: Design and manage stability studies according to ICH guidelines, analyze stability data, and ensure drug-excipient compatibility.
3. Troubleshooting & Process Improvement: Identify and address issues during batch execution, providing troubleshooting solutions and contributing to continuous process improvement.
4. Conduct literature research and prepare presentations to support formulation development.
5. Characterize reference products (RLDs) to guide new product formulations.
6. Ensure proper documentation of experimental results in compliance with cGMP.