Wenbing Hu
VP of CMC @ Bambusa Therapeutics
About
Highly motivated drug development expert in the biopharmaceutical industry. Extensive knowledge and experience in analytical development and quality control for drug development. Experienced CMC leader for whole range of CMC development activities. Thorough understanding of cGMP and ICH quality guidelines. Major author and reviewer of CMC sections for regulatory filing such as IND and IMPD. Excellent organization skills and ability to multi-task and manage priority in a fast-paced and team-orientated environment.
United States
San Diego
Pharmaceuticals
Mass Spectrometry, H/D exchange MS, Epitope mapping, Protein Chemistry, Protein Folding, Analytical Chemistry, Matlab Programming, Proteomics, LC-MS, Biophysics, Protein Structure, Protein-ligand binding, HPLC, Biochemistry, Protein Purification, Protein-protein Interactions, Protein Expression, Antibodies, Fluorescence, Biotechnology
Experience
VP of CMC
Bambusa Therapeutics
Boston, Massachusetts, United States
Head of CMC – Lead and oversee all CMC activities across Bambusa’s pipeline, driving the development, execution, and strategic management of CMC programs.
Senior Director
Ansun Biopharma, Inc.
San Diego, California, United States
Manage in-house and outsourced CMC activities to support DAS181 phase III pivotal trial and BLA preparation.
Sr. Director, Analytical Development and Quality Control
Sorrento Therapeutics, Inc.
San Diego, California, United States
• Analytical methods development and qualification/validation for biological drugs. Write, review and approve SOPs, validation protocols and reports. • Comprehensive characterization of large molecule product quality attributes. Development of specifications through various development stage for new drug substance and product. • Manage Quality Control lab for in-process and product release tests, reference standard and stability program. • Development of stable and robust formulation for therapeutic proteins. • Author CMC related sections for IND and IMPD.
Director, Analytical Development and Quality Control
Sorrento Therapeutics, Inc.
San Diego
Associate Director, Analytical Development and Quality Control
Sorrento Therapeutics, Inc.
Greater San Diego Area
Group leader, Analytical Development and Quality Control
Sorrento Therapeutics, Inc.
Greater San Diego Area
Scientist, Analytical Development and Quality Control
Sorrento Therapeutics, Inc.
Researcher
University of Pennsylvania
Philadelphia
Develop innovative mass spectrometry methods to study therapeutic protein structure, function and stability, and map antibody epitopes on target antigens for autoimmune TTP diseases.
Wenbing Hu's Contact Information
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