Brian Zedalis
Associate Director, CMC @ Forte Biosciences, Inc.
About
I’m a driven process scientist dedicated to delivering medicines to patients. A cell culture biochemist with 11+ years in drug development and GMP manufacturing. Experienced in leading cross-functional teams related to tech transfer, development, and production of biologics drug substance. Motivated in advancing critical CMC milestones of early, late, clinical, and commercial projects within internal and external CDMO partners. Specialties: Biologics Process Development (Cell Line and Upstream), Tech Transfer, GMP Manufacturing, Bioreactor Engineering, Cell Culture, Process Control and Validation, Cell Biology, and External CDMO oversight
United States
San Diego Metropolitan Area
Biotechnology
CMC, Drug Substance Manufacturing, Late Stage Tech Transfer, Commercialization, Process Performance Qualification, Glycan Control, Early Phase Process Development, Process Optimization, Late Stage Process Development, Process Control, DOE, High Throughput, Process Characterization, Cell Therapy, Bioreactor Scaling, Mammalian Cell Culture, Technology Transfer, Process Validation, Product Development, PPQ
Experience
Associate Director, CMC
Forte Biosciences, Inc.
Manager / Scientist
Gilead Sciences
Oceanside, CA
Technology Transfer - Drug Substance
Associate Scientist
Gilead Sciences
Oceanside, California, United States
Cell Line and Upstream Process Development
Senior Research Associate II
Gilead Sciences
Oceanside, California, United States
Upstream Process Development (Biologics / Cell Therapy)
Senior Research Associate I
Gilead Sciences
Oceanside, California, United States
Associate II (GMP Manufacturing and Upstream Bioprocess Development)
MacroGenics, Inc.
Rockville, Maryland, United States
Graduate Researcher
Georgetown University School of Medicine
District of Columbia, United States
Undergraduate Researcher
Purdue University
West Lafayette, Indiana, United States
Food Science Intern
Cadbury Adams USA LLC
East Hanover, New Jersey, United States
Business Development Intern
Ansell
Red Bank, New Jersey, United States
Education
Purdue University
Biochemistry and Molecular Biology
Georgetown University School of Medicine
Biochemistry / Biotechnology
Brian Zedalis's Contact Information
Phone
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