16 + Years experience in Research and Development and currently working as a Senior Manager in Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad, India in Formulation Research & Development Dept. of Complex Injectables/Sterile Products.Job Responsibilities:1. To develop the robust storage-stable formulations of sterile products (which includes Ophthalmics, Injectables, Inhalation Solutions, Otic Solutions).2. To coordinate and carry out the projects for US, Europe, and Rest of world markets.3. To manage and lead the team of scientists to work on a firm belief of TEAM (Together Everyone Achieves More).Technical Exposure:1. Scientific literature survey, patent review & patent strategy for sterile products including Ophthalmics, Injectables, Otics and Inhalations-Nebulizers.2. Experience to decide and determine the Project Feasibility, Project Strategies and Project Timelines.3. Working experience with development of aqueous injectable solutions, non aqueous (oil based) injectable solutions and lyophilized injectable products. 4. Working experience with development of Peptide Molecules, Oncology/ Cytotoxic (Anti-cancer) and Hormonal injectable products.5. Working experience of Injectable Products in Vials, Ampoules, Pre-filled Syringes, COP/COC Vials and Cartridge Device.6. Experience with formulation development of ophthalmic suspensions and emulsion in BFS (Blow-fill-seal) and 3 Piece containers.7. Working experience with CROs/ CMOs (Worked with US and Europe CROs/CMOs) and ability to get the task done within stipulated time frame.8. Execution of the developmental trial batches at R & D, their process development for various regulated markets.9. Basic knowledge of Design of Experiment and Quality by Design.10. Exposure to execution of the Exhibit/ Submission Batches for sterile Ophthalmic, Injectable, Otic and Inhalation (Nebulizer) products.11. Preparation of Product Development Reports, Master Documents and other relevant documents during product development and regulatory submissions.12. Experience of Research Laboratory Set Up and Lab Development.13. Exposure of US FDA, MHRA audit for injections and ophthalmics.14. Coordination with other departments and cross functional teams for smooth execution of projects.15. Good Communication Skill during working with CFTs.
Listed skills include Formulation Development, Anda, Generics, Pharmaceuticals, and 21 others.