George Soder
Senior Director - Large Molecule Analytical Validation at Merck | New York City Metropolitan Area
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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.
Senior Director - Large Molecule Analytical Validation at Merck in October 2022 to Present
Principal Scientist at Merck in January 2012 to December 2022
Director - Analytical Program Leadership at Merck & Co. in June 2019 to December 2022
Assoc. Princ. Scientist at Merck in January 2006 to January 2012
Senior Scientist at Merck in January 2003 to January 2009
Associate Scientist at Schering-Plough Research Institute in January 1997 to January 2003
Scientist II at Schering-Plough Research Institute in January 1994 to January 1997
Assistant Scientist at Schering-Plough Research Institute in March 1991 to January 1994
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Validation
Bioanalysis
LIMS
Clinical Trials
Biomarker Discovery
Drug Discovery
GLP
Clinical Development
Biomarkers
In Vitro
Biotechnology
Immunology
CMC development
Regulatory Submissions
Bioprocess
Analytics
Assay Development
Biopharmaceuticals
Drug Development
Pharmacokinetics
Cross-functional Team Leadership
Pharmaceutical Industry
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Discover more about MerckWhat is George Soder email address?
Email George Soder at [email protected]. This email is the most updated George Soder email found in 2026.
How to contact George Soder?
To contact George Soder send an email to [email protected]. (updated on September 13, 2024)
What company does George Soder work for?
George Soder works for Merck
What is George Soder's role at Merck?
George Soder is Senior Director - Large Molecule Analytical Validation
What is George Soder's Phone Number?
George Soder's phone (212) ***-*524
What industry does George Soder work in?
George Soder works in the Pharmaceutical Manufacturing industry.
George Soder Email Addresses
George Soder Phone Numbers
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