Adam Lucka
About Adam Lucka
Adam Lucka serves as the Global Program CMC Lead at Rallybio, where he has worked since 2021. He has a strong background in analytical medicinal chemistry and extensive experience in CMC management, having previously held various roles at Alexion Pharmaceuticals.
Work at Rallybio
Adam Lucka serves as the Global Program CMC Lead at Rallybio, a position he has held since 2021. In this role, he is responsible for managing site selection decisions within the overall CMC strategy. He oversees the performance and delivery of contract manufacturing organizations (CMOs) for drug substance and drug product in support of clinical studies. His work contributes to the efficient development and manufacturing processes within the organization.
Previous Experience at Alexion Pharmaceuticals
Prior to his current role, Adam Lucka worked at Alexion Pharmaceuticals, Inc. for a total of seven years in various capacities. He began as Scientist I in Protein Characterization from 2003 to 2006, then progressed to Scientist II in the same department from 2007 to 2012. He later took on the role of Associate Director, Technical Project Management in 2013 for 11 months, and served as Senior Director, Product Development Operations from 2014 to 2021. His responsibilities included performing CMC reviews, root cause analyses, and regulatory filings.
Education and Expertise
Adam Lucka earned a Master of Science in Analytical Medicinal Chemistry from Purdue University, where he studied from 1997 to 2001. He also holds a Dual Certification in Regulatory Affairs for Medical Devices and Pharmaceuticals from the Regulatory Affairs Professional Society, achieved in 2011. His educational background supports his extensive experience in CMC management and regulatory compliance.
Background in Engineering and Science
Before his tenure at Alexion, Adam Lucka worked at Agilent Technologies as a Field Services Engineer for nine months in 2006. His early career included roles that focused on scientific research and technical project management, which laid the groundwork for his later achievements in the pharmaceutical industry. His diverse experience has equipped him with skills in building synergy across business units and facilitating data synthesis.
Professional Skills and Responsibilities
Adam Lucka has extensive experience in managing CMC due diligence for in-license and asset acquisition opportunities. He has coordinated numerous CMC reviews and regulatory filings, demonstrating his proficiency in navigating complex regulatory environments. His ability to facilitate collaboration across diverse teams enhances operational efficiency and supports the successful development of pharmaceutical products.