Deputy Manager/Manager R & D (Ophthalmic)

JOB RESPONSIBILITIES Formulation development of Complex ophthalmic dosage form for ROW and regulated market. Good knowledge of design and development of ophthalmic formulations such as sterile solutions, suspensions, emulsions, gel, preservative free and multidose systems. Q1/Q2/Q3 equivalence, Pharmaceutical In-vitro studies, In-vivo PD studies for generic development.

In depth know how on product development strategy, pathway, Container closure system, performance assessment, stability studies. Development using Quality by Design, Risk assessment and mitigation strategy for Product and process attributes. Should have good knowledge of ICH, MEPP, US/UK/ROW regulatory requirements and working in aseptic, sterile environment.

Hands on experience on Lab-Pilot- Mfg. scale equipment, scale up principles, Batch mfg, process flow design and technology transfer of ophthalmic dosage form. Sterilization, Validation, homogenization, emulsification process understanding. Abreast with good document practices and adept in preparation, review of R&D, TT documents.

Understanding on Specs, dossier studies and new requirements like nitrosamine risk assessment and risk mitigation strategies. PDR preparation and response to regulatory agency queries based on product need. Plan and execute the development projects as per timelines and guide junior scientist for experimental work and ensure milestone delivery.

Effective co-ordination with cross-functional teams and contributing to the delivery and achievement of milestones. If interested pls contact 9589659889