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Technical Manager - ESO - MS&TJul 2013
Providing expert CMC and technical expertise whenever it is needed RA and evaluation risk of the CMO. Responsible for development and technology transfer of drug products from development to commercial scale Troubleshooting/investigations/optimization of existing commercial manufacturing processes. Process improvement Continous validation. Contract manufacturing Prelimininary Risk assessment of RnD and Commercial site, Investigator,CAPA, Change control,
Associate Manager - Drug Product DevelopmentFeb 2010 - Jul 2013 (3 years)
Design, execute, and interpret formulation and process development experiments leading to the development and optimization of various oral pharmaceutical forms and dds. Preformulation studies for NCE Development of Suspension, Capsule, tablets required for Phase I, II, & III [login to view URL] collaboration within international teams (Analytical, Manufacturing, Quality Control and Quality Assurance, Purchasing, Regulatory, Packaging, Suppliers of raw material
Associate Scientist - formulationNov 2005 - Feb 2010 (4 years)
New Product Development for [login to view URL] on CR / MUPS/Immediate release dosage forms. Products with suitability petition. Preparation of strategies and action plan for patent infringing and non-infringing formulation for ANDA. Preparation and compilation of Master Formulae Card. Preparation and compilation of Product Development report. Stability protocol for exhibit batches, finished products and regulatory specifications. Preparation of Specification and In-process specification.
Officer - FormulationsMay 2004 - Oct 2005 (1 year)
Worked of ODT, Pelletization, compression, Extruder Spheronization technologyies.