Formulation and Development Scientist

About This Role

Formulating and developing sterile ophthalmic products is the core of this scientific role, involving optimization at various scales and supporting their transfer to manufacturing. The role suits a scientist with expertise in sterile dosage forms and a commitment to quality and regulatory compliance.

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