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.
Location Hyderabad
Website [Confidential Information]
Salary Best in Industry
EXPERIENCE NEED Minimum 2+ years in Formulation R&D
