Job Title: Research Scientist Ophthalmic Formulation Development

Role & Responsibilities

- Develop and optimize complex ophthalmic dosage forms for regulated and ROW markets.
- Design and develop sterile ophthalmic formulations including solutions, suspensions, emulsions, gels, preservative-free products, and multidose systems.
- Conduct formulation screening, prototype development, and support Q1/Q2/Q3 equivalence studies for generic product development.
- Execute pharmaceutical in-vitro studies and support in-vivo pharmacodynamic (PD) studies as required.
- Perform pre-formulation and formulation development activities, including excipient compatibility and container closure system evaluations.
- Apply Quality by Design (QbD) principles, risk assessment, and mitigation strategies during product and process development.
- Prepare and review development protocols, technical reports, product development reports (PDRs), and technology transfer documents.
- Conduct stability studies and evaluate product performance throughout the development lifecycle.
- Support scale-up activities from laboratory to pilot scale and assist in technology transfer to manufacturing sites.
- Operate and maintain laboratory and pilot-scale equipment used for ophthalmic product development.
- Ensure compliance with ICH guidelines and regulatory requirements for US, EU, UK, and ROW markets.




- Participate in investigations related to formulation, process, and stability issues and recommend corrective actions.
- Assist in sterilization process development, validation activities, homogenization, and emulsification process optimization.
- Contribute to dossier preparation, specification development, nitrosamine risk assessments, and responses to regulatory queries.
- Maintain accurate documentation and adhere to Good Documentation Practices (GDP) and data integrity requirements.
- Collaborate effectively with Analytical Development, Regulatory Affairs, Manufacturing, Quality Assurance, and other cross-functional teams to achieve project milestones.
- Support project planning and execution to ensure timely delivery of development objectives.

Preferred Candidate Profile
- M.Pharm / Ph.D. in Pharmaceutics, Pharmaceutical Technology, or related discipline.
- Experience in ophthalmic formulation development within a regulated pharmaceutical environment.
- Strong understanding of sterile manufacturing processes, aseptic techniques, and ophthalmic product development.
- Knowledge of regulatory requirements, QbD principles, and product lifecycle management.
- Positive analytical, problem-solving, documentation, and communication skills.

📌 Research Scientist-Ophthalmic (Mumbai)
🏢 Navlakha Management Services
📍 Mumbai