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 Valuable Documentation Practices (GDP) and data integrity requirements.
Collaborate effectively with Analytical Development, Regulatory Affairs, Manufacturing, Quality Assurance, and other

📌 Research Scientist Ophthalmic Mumbai
🏢 Navlakha Management Services
📍 Mumbai