ey Responsibilities

• Develop and optimize formulations for injectable (liquid, lyophilized) and/or OSD (tablets, capsules) dosage forms.
• Conduct pre-formulation studies including API characterization, solubility, stability, compatibility, and excipient selection.
• Design and execute formulation experiments, DoE (Design of Experiments), and process optimization studies.
• Prepare laboratory batches and evaluate critical quality attributes (CQAs) such as assay, dissolution, sterility (INJ), content uniformity, and stability.
• Support scale-up and technology transfer activities from R&D to pilot and commercial manufacturing.
• Prepare formulation development reports, protocols, and regulatory documentation (CTD/ANDA support if applicable).
• Work closely with Analytical R&D, QA, QC, and Production teams for method development and validation support.
• Evaluate stability data and recommend formulation improvements.
• Ensure compliance with cGMP, GLP, data integrity, and internal R&D guidelines.
• Participate in troubleshooting during scale-up and manufacturing batches.
• Stay updated with current pharmaceutical development trends, regulatory expectations, and innovation in formulation science.