Job title: Associate Director, CMC-Regulatory Affairs, Gene & Cell Therapy
Karen currently specializes in CMC regulations and strategy for Janssen’s Cell and Gene Therapy division. Her prior work includes being the project manager of process/product development of biologics and therapeutics for clinical trials in companies such as Eli Lilly, Pfizer, Dendreon Corporation as well as organizations of Seattle Children’s Research Institute,Fred Hutchinson Cancer Research Center, and University of Chicago.
Karen is a PhD-level principal research scientist with extensive knowledge and laboratory experience in immunotherapy, molecular biology, cellular biology, neuroscience, and biochemistry investigating signal transduction pathways, tumor microenvironment, and cell-cell interactions with in vitro cell cultures and in vivo animal models at both academic and industry settings.
She has managed pre-clinical validation studies and authored CMC modules for a variety of health authority filings for both clinical trials and commercial marketing applications with the FDA, NIH, Health Canada, EMA, and Japan. With a range of scientific accomplishments and 25+ peer-reviewed scientific publications, Karen makes a strong leader, manager and contributing cross-functional collaborator with a successful track record of driving and meeting milestones from target discovery to product development to clinic.
Location: Lebanon, Tennessee, United States
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