Analytical Leader in Biologics and Cell and Gene therapy
Life Science and CMC Analytical Development leader with 10+ years of experience advising and leading analytical strategy across monoclonal antibodies and advanced therapies, including AAV9, lentiviral vectors, and retroviral vectors. Proven expertise in assay development, qualification/validation, analytical control strategy, tech transfer, and reference standard lifecycle management within GLP/GMP-regulated environments. Strong track record supporting biotech startups, CDMOs, and sponsors through clinical development, CRO/CDMO oversight, and regulatory-aligned documentation. Adept at building teams, establishing laboratories, and delivering fit-for-purpose analytical solutions from early development through commercialization.
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