Roles & Responsibilities
Develop and optimize sterile ophthalmic formulations, including ophthalmic solutions, suspensions, and emulsions.
Conduct formulation development and process optimization at laboratory scale and support scale-up to pilot/production scale.
Perform technology transfer of sterile dosage forms from R&D; to manufacturing sites.
Coordinate with manufacturing, QA, QC, and other cross-functional teams during scale-up and technology transfer activities.
Provide technical support and troubleshooting for commercial batches and manufacturing-related issues.
Investigate and support resolution of OOS, OOT, deviations, process-related issues, and formulation-related problems.
Participate in root cause analysis and implementation of corrective/preventive actions (CAPA).
Prepare and review formulation and process-related documents such as MFR, BMR, development reports, stability protocols, and stability reports.
Monitor stability studies and evaluate formulation/product performance.
Ensure formulation development activities comply with GMP and applicable regulatory requirements.
Visit different manufacturing sites as required for technology transfer, scale-up, troubleshooting, and commercial batch support.
Maintain proper technical documentation and ensure timely completion of assigned R&D; projects.
Work closely with cross-functional teams to ensure successful product development, scale-up, and commercialization.
📌 Formulation And Development Scientist Mumbai (India)
🏢 Navlakha Management Services
📍 India
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