Douglas Malkin

Principal Scientist @AbbVie

Responsible for leading the analytical aspects of a project while working with other functional areas to advance small-molecule projects through the development pipeline • Responsible for method development, testing procedures, and implementation of analytical control strategies to help the advancement of drug discovery candidates. • Enable new product development with advanced methods development and validations, technical transfer packages, and generation of technical data in support regulatory requirements. • Utilize understanding of a range of analytical techniques to conduct research and development studies related to small-molecule drug products, drug substances, intermediates, starting materials, impurities, and impurity profiling • Apply analytical separation and detection modes for complex impurity profiling of pharmaceutical products to further the understanding of emerging cGMP manufacturing processes. • Collaborate with third party laboratories for outsourced programs to ensure CMC timelines are met. • Author and/or review key regulatory documents, laboratory data, technical memos and reports. • Identify new analytical technologies and optimize existing methodologies, instruments and technologies. • Lead an automated sample preparation team looking at increasing the use of automation to increase overall operational effectiveness of the organization • Lead proactive recruiting for analytical R&D in Development Sciences