- Supervise Formulation & Development (F&D;) activities and monitor operators/assistant operators within designated premises at the site.
- Conduct literature and patent searches and review findings as per product development requirements.
- Perform innovator and market sample characterization for comparative evaluation.
- Plan and execute day-to-day F&D; trials for Domestic, ROW, and other regulatory markets.
- Lead formulation development from pre-formulation studies through lab-scale development, scale-up, technology transfer, and exhibit batch manufacturing.
- Plan and execute pre-formulation studies to support product development objectives.
- Execute development trials to achieve desired critical quality attributes (CQAs) and prepare stability batches as per project timelines.
- Identify and implement improvements in existing formulations and explore potential for current dosage forms.
- Ensure timely completion of assigned formulation development and technology transfer activities.
- Coordinate with the Analytical Department for routine analysis, in-process checks, and evaluation of developed formulations.
- Prepare and review technical documentation, including Product Development Reports (PDRs), Master Formula Records (MFRs), and Technology Transfer documents.
- Ensure compliance with cGMP, GLP, and internal quality systems during all stages of formulation development.