Lauren MacDonough

Lauren MacDonough is a seasoned professional in the biotechnology and pharmaceutical sectors with extensive experience in regulatory affairs, technical writing, and quality control. Currently serving as Senior Manager in CMC Regulatory Affairs Technical Writing at Amicus Therapeutics since March 2022, Lauren previously engaged as an entrepreneur at FedTech from November 2022 to May 2023, focusing on cutting-edge technology under guidance from industry leaders. Prior experience includes a Senior Associate role at Eisai US, where responsibilities encompassed analytical CMC activities for clinical drug product development. Earlier positions include Technical Writer at Sanofi Pasteur, Document Specialist at McNeil Consumer Healthcare, and Quality Control Analyst at Auxilium Pharmaceuticals, showcasing a strong background in compliance and quality assurance practices. Lauren holds a Master’s degree in Biotechnology Enterprise and Entrepreneurship from Johns Hopkins University and a Bachelor of Science in Biochemistry and Molecular Biology with Neuroscience from Ursinus College.