SUMMARY: * A pharmaceutical scientist with more than 15 years of experience supporting product development activities in an FDA regulated environment. * Seeking a position where my knowledge and skills in Pharmaceutical Product Development and CMC documentation can be applied with a potential for professional growth. * Skilled in the application of various physico-chemical analytical techniques in raw material and finished product characterization. * Has solid knowledge of various pharmaceutical unit operations, manufacturing processes and processing equipment. * Understands the applicable regulatory requirements for new drug product development to obtain FDA approval. * Experienced in the preparation, organization and presentation of technical documents for Module 2.3.P and Module 3.2.P of the electronic Common Technical Document (eCTD) for submission to regulatory agencies
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