Research Scientist-Ophthalmic

Navlakha Management Services; Mumbai; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

Navlakha Management Services seeks a Research Scientist in Ophthalmic Formulation Development to lead design, development and optimization of sterile ophthalmic dosage forms for regulated markets, including QbD and regulatory compliance.

The ideal candidate holds an M.Pharm or Ph.D. in Pharmaceutics or related field with experience in regulated ophthalmic development, sterile processes, and quality documentation. Mumbai site offers growth in biotech pharma projects.

Qualifications

• M.Pharm or Ph.D. in Pharmaceutics or related field.
• Experience in ophthalmic formulation development in regulated pharma.
• Strong understanding of QbD, sterile manufacturing, and regulatory requirements.

Responsibilities

• Develop and optimize ophthalmic dosage forms for regulated and ROW markets.
• Design sterile ophthalmic formulations including solutions, suspensions, emulsions, gels, preservative-free products, and multidose systems.
• Conduct formulation screening, prototype development, and support equivalence studies for generic product development.
• Execute in-vitro studies and support in-vivo pharmacodynamic studies as required.
• Perform pre-formulation and formulation development activities, including excipient compatibility evaluations.
• Apply QbD principles, risk assessment, and mitigation strategies during product and process development.
• Prepare development protocols, technical reports, PDRs, and technology transfer documents.
• Conduct stability studies and evaluate product performance throughout development.
• Support scale-up activities from lab to pilot scale and assist in technology transfer to manufacturing sites.
• Operate and maintain lab and pilot-scale equipment for ophthalmic product development.
• Ensure compliance with ICH guidelines and regulatory requirements for US, EU, UK, and ROW markets.
• Participate in investigations and recommend corrective actions.
• Assist in sterilization process development, validation, and emulsification process optimization.
• Contribute to dossier preparation, specification development, nitrosamine risk assessments, and regulatory queries responses.
• Maintain GDP and data integrity in documentation.
• Collaborate with Analytical Development, Regulatory Affairs, Manufacturing, QA, and cross-functional teams to achieve milestones.
• Support project planning and execution to ensure timely delivery of development objectives.

Skills

Analytical thinking

Problem-solving

Documentation

Communication skills

Education

M.Pharm / Ph.D. in Pharmaceutics or Pharmaceutical Technology

Job description

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.
• Good analytical, problem-solving, documentation, and communication skills.