Formulation and Development Scientist

Navlakha Management Services; Mumbai; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Navlakha Management Services in Mumbai is seeking a formulation scientist to develop and optimize sterile ophthalmic formulations, including solutions, suspensions, and emulsions, with support for scale-up to pilot and production.

You will coordinate with manufacturing, QA, QC, and other cross-functional teams during scale-up and technology transfer activities, investigate OOS/OOT deviations, review study documents, and ensure GMP compliance throughout development and transfer processes.

Qualifications

• Develop and optimize sterile ophthalmic formulations (solutions, suspensions, emulsions).
• Formulation development and process optimization at lab scale.
• Support scale-up to pilot/production scale.
• Technology transfer of sterile dosage forms from R&D to manufacturing sites.

Responsibilities

• Develop and optimize sterile ophthalmic formulations for various dosage forms.
• Coordinate with cross-functional teams during scale-up and technology transfer activities.
• Provide technical support and troubleshooting for commercial batches and manufacturing issues.
• Investigate OOS, OOT, deviations, and formulation-related problems.

Job description

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.