George Soder is a seasoned analytical scientist with over thirty years of experience in biotechnology drug development, currently serving as a Senior Director at Merck within the Analytical Research and Development division. In this pivotal role, George leads a dedicated team of Analytical Working Group...
George Soder is a seasoned analytical scientist with over thirty years of experience in biotechnology drug development, currently serving as a Senior Director at Merck within the Analytical Research and Development division. In this pivotal role, George leads a dedicated team of Analytical Working Group leads, driving the progression of large molecule programs from Phase 3 clinical trials through to commercial registration. His extensive expertise encompasses a broad spectrum of responsibilities, including analytical method development for both release and stability, phase-appropriate method validation, and the meticulous transfer of analytical methodologies.
George plays a crucial role in shaping the overall control strategy for biotherapeutics, ensuring that analytical program deliverables align with regulatory requirements and industry standards. His leadership in analytical validation and transfer processes is instrumental in maintaining the integrity and reliability of data generated throughout the drug development lifecycle. Additionally, George is adept at managing relationships with Contract Manufacturing Organizations (CMOs), overseeing specification development, stability studies, and comparability assessments to ensure that products meet stringent quality benchmarks.
His proficiency in Laboratory Information Management Systems (LIMS), Good Laboratory Practice (GLP), and regulatory submissions further enhances his ability to navigate the complexities of drug discovery and development. With a strong foundation in immunology and pharmacokinetics, George is not only a key contributor to the success of large molecule programs but also a mentor and thought leader within the analytical community at Merck. His commitment to advancing biotherapeutic innovations underscores his passion for improving patient outcomes through scientific excellence.
