Salina Chowdhury

Development Manager @Patrin Pharma, Inc

Managing projects, collaborating with CRO, Manufacturing companies, Packaging companies, Testing labs • ANDA submission, correspond to Agency for complete response & deficiency letters • Establish GMP compliant Laboratory • Review, approve technical documents, data, report; and communicate manage progress of project with CDMO, CRO • Support Drug Development using a variety of analytical techniques; conduct research & development to drug products, API, intermediates, starting materials, impurities, and impurity profiling • Executing analytical method development and characterization of drug products (FP), impurity isolation and characterization, pre-formulation, compatibility, force degradation, and stability study • Ensure all laboratory operations (training, equipment, data generation, documentation, and review) • Leading all operation & managerial responsibilities for new product development activities: early product development to scale-up and regulatory on analytical aspects of a project through the development pipeline. • R&D development work & evaluation and management of lab work completed by others – inside and outside the company. Documentation and communication the project progress • Formulation (Solution, Suspension, Gel, Otic, Body and Scalp Oil); Analyzing (HPLC with PDA, Disintegration, pH, Titration, viscometer); evaluate results; documentation and report. • Perform testing / investigation GMP/GLP type environment in support of R&D prototype formulations, raw materials, and stability testing; draft SOP/OOS/OOT/CAPA/Memorandum • Handling Customer Complain, inquiry and investigation as needed • Perform analytical method development, testing and validation; assist in identifying sources for API, excipients, and components; Evaluate external products. • Make effective decisions when presented with multiple options for how to progress with the project • Perform quality control on the project throughout development to maintain the standards expected