Carolyn Hsu
About Carolyn Hsu
Carolyn Hsu is the Associate Director of R&D Integration & Program Management at Alkermes in Waltham, Massachusetts, with nearly 20 years of experience in the biopharmaceutical industry.
Current Role and Responsibilities
Carolyn Hsu is the Associate Director of R&D Integration & Program Management at Alkermes in Waltham, Massachusetts, United States. In this role, she oversees the integration of research and development efforts, ensuring alignment with strategic objectives. Her responsibilities include coordinating project management activities, driving process efficiencies, and facilitating cross-functional communication to support program goals.
Previous Experience at AbbVie
Carolyn Hsu has extensive experience at AbbVie, where she held several senior roles. From 2019 to 2020, she served as the Sr. Business Manager for Knowledge Management in Worcester, Massachusetts. From 2015 to 2019, she was a Sr. Project Manager for Biologics CMC Program Management. Prior to that, she worked as a Sr. Scientist-II in CMC Program and Manufacturing Project Management from 2013 to 2015.
Early Career at Abbott Bioresearch Center
Carolyn Hsu began her career at Abbott Bioresearch Center. She held a variety of positions, including Sr. Scientist-II in CMC Program Management from 2010 to 2012 and Sr. Scientist-I in Technical Operations, Global Pharmaceutical Operations from 2007 to 2010. Before these roles, she was a Sr. Research Scientist from 2001 to 2007, focusing on Global Pharmaceutical Operations.
Academic Background
Carolyn Hsu studied Chemistry at Michigan State University, where she earned a Doctor of Philosophy (PhD). She also studied at National Taiwan University, gaining foundational knowledge that would later inform her career in the biopharmaceutical industry.
Specialized Expertise
Carolyn Hsu has led process validation and performance qualification activities for drug registration, ensuring regulatory compliance. She has improved recovery and purification processes for biologics and microbial antibiotics, enhancing product quality. She has also been instrumental in supporting digital transformation initiatives, managing pipeline product portfolios, and coordinating CMC activities for regulatory filings such as IND, IMPD, BLA, and MAA.