Samuel Yang

About Samuel Yang

CMC leader - analytical project lead (early development/DRF tox through Phase 3 clinical)- small molecule development/synthetic peptide/polymer-mAb conjugate/oligonucleotide project and regulatory CMC filing authoring. Manager and Group Lead of scientists to support project responsibilities. Includes extensive partnership experience with external contract manufacturing organizations in combination with internal development- Establishment of the overall control strategy for clinical API/drug substance and formulation/clinical drug product (solid dosage form, long acting delivery, and unique drug delivery modalities), including all supportive analytical data/activities towards IND filing to regulatory health agencies- Synethetic Peptide Therapeutics Development - Drug Development as analytical lead from pre-clinical candidate nomination to manufacture and IND authoring for clinical FPI/Phase 1. Early phase platform candidate screening strategy for preclinical candidates to establishment of analytical control strategy and method development for clinical phase peptide therapeutics from with the Drug substance manufacture and the DP liquid formulation parental manufacture- Functionalized-Polymer - CMC Lead - Development of manufacturing and control strategies of functionalized PEG scaffolds for therapeutic antibody conjugation- Functional expert in analytical development and CMC lead for characterization of peptides and oligonucleotides. Focus analytical methodology towards implementation of control strategy for clinical manufacture at partnered external contract manufacturing companies- Development lead in GTI control strategy using available analytical techniques (e.g. LC-MS, ICP-MS, derivatization LC methods) to characterize and quantitate low level GTIs/pGTIs- Characterization of new drug compounds using innovative Two Dimensional - Liquid Chromatography (2D-LC) strategies, use of multidimensional chromatography to characterize complex protein-polymer-drug payload molecules and development of platform 2D-LC screening methodology- Analytical Characterization and Development lead in conjugated antibody-polymer hybrid therapeutics focusing on the polymer scaffolds and their interaction with protein-polymer conjugates. Special focus on creating control strategy and characterization methodology for functionalized PEG and Hylauronic Acid derivatives and cross-linked hydrogel materials.

Experience

1. Senior Principal Scientist

   Genentech

   Sep 2024 — Present

Education

• The University of Texas at Austin

  Bachelor of Science (B.S.), Biochemistry

  2002 — 2007

• The University of Texas at Arlington

  Doctor of Philosophy (Ph.D.), Chemistry (Analytical)

  2007 — 2012