Son Nguyen
Director, Drug Cmc and Bioanalytics @Rani Therapeutics
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WORK HISTORY
Director, Drug Cmc and Bioanalytics @Rani Therapeutics
San Jose, CA, US
Development of drug device combination products. Responsible for all aspects of drug CMC (including formulation development of solid dosage form), and bioanalytics (PK and ADA ligand binding assay development and validation) for small peptides, antibodies, protein drugs.
ABOUT SON NGUYEN
I am a biotech professional with proven track record of founding analytical development and quality operations in three successful start-up companies to support CMC development and discovery research. I am known for exceptional creativity, leadership qualities, high energy, and can-do attitude. I am a subject matter expert in analytical development, quality control, and pharmaceutical development from concept to NDA approval and successful launch (large and small molecules). I am seen as a successful builder of high-performance, cross-functional teams developing and implementing novel analytical technologies in a resource-constrained and fast-paced environment. I am an effective communicator with strong interpersonal skills.(Bio)Analytical Development: • Method Development • Liquid Chromatography • Gas Chromatography • Electrophoresis • Mass Spectrometry • Spectroscopy • Light Scattering & Diffraction • Functional Bioassays • Biophysical Assays • Structure Characterization Quality Control: • Method Transfer • Method Validation • Stability Program • Reference Standards • Comparability Testing • Bioequivalence Testing • Dissolution • Life Cycle Management Additional Experience: • Quality Systems • Authoring NDA/IND/IMPD • Compendial USP/EP/JP • ICH, FDA, EMA, WHO Guidelines • OOS Deviation Investigation • GLP cGMP & Regulatory Compliance • Quality Audits • Quality Agreements • Pre-approval Inspections • PK PD TK DMPK ADME • Drug-drug Interactions • Formulation Development • Technology Transfer • API & DP Manufacturing • Lifecycle Management (Methods, Products) • Statistical Tools for Comparability Assessments and Trending • Post-approval Changes
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