Key Responsibilities

- Conduct formulation development for injectable products, including lyophilized injections and complex injectables.
- Perform lab-scale experiments, stability studies, and process optimization.
- Draft and maintain Product Development Reports (PDRs) and other technical documentation.
- Ensure compliance with ICH guidelines and regulatory standards during development.
- Support regulatory submissions by providing technical data and documentation.
- Collaborate with cross-functional teams (QA, RA, Manufacturing) to ensure smooth product development and transfer.
- Stay updated on regulatory requirements and market trends in injectables.

Qualifications & Experience

- Masters degree in Pharmaceutics, Pharmaceutical Sciences, or related field.
- 5–8 years of hands-on experience in injectable formulation development.
- Practical knowledge of lyophilization techniques and complex injectable formulations.
- Experience in PDR writing and documentation aligned with ICH guidelines.
- Exposure to regulatory market requirements (US, EU, ROW).
- Robust analytical and problem-solving skills.

📌 Officer/Senior Officer- FRD (Indore)
🏢 Gufic Biosciences
📍 Indore