Assistant Manager-Formulation Development-Ophthalmic

Scientific literature survey, patent review for sterile products Ophthalmic

Development of Injectables and Complex Ophthalmic formulations for Regulated markets. Troubleshooting of Complex Ophthalmic Product (Emulsion)

Plan and conduct scientific experiments to create prototype product and record accurate and complete experimental methods and results.

Working on different sterilization techniques (Filtration and Terminal sterilization). Instrument Handling: High pressure Homogenizer, Inline-Homogenizer, Malvern (Zetasizer)

Documentation:

Develop experimental protocols and work plan for laboratory experiments and prepare reports with conclusions and recommendations.

Preparation of documents like Stability protocol, MFR, PDRF, BOM, Elemental impurities testing protocol etc.

Review test results in alignment with the project goals, identify causes of variances and recommend solutions to achieve goals.

Review of various other documents like filter validation, BMR, Elemental impurities testing reports etc. Providing required documents for Regulatory submission.

Scale Up and Technology Transfer:

Preparation of Master documents (MFR, PDRF, Stability Protocol, BOM etc.). Execution of Scale up & Submission batches.