Jenny Wang
Senior Director, Biologics Potency at Gilead Sciences
- Role
- Senior Director, Potency & Functional Characterization at Gilead Sciences
- Location
- San Diego, CA, US
- LinkedIn followers
- 500 followers
Experience
Senior Director, Potency & Functional Characterization
Mar 2014 — Present · San Diego, CA, US
Leading Potency and Functional Characterization function to develop and validate ELISA, flow cytometry, cell-based bioassays and process impurity assays from FIH through BLA to support development and manufacturing of mAbs, fusion proteins, bispecifics, antibody drug conjugates. Establishing phase-appropriate potency and extended characterization strategy for pipeline biologics. Managing CTLs and internal QC labs for validation, transfer, release/stability testing of commercial products and late stage molecules. Managing potency assay lifecycle to improve robustness and QC operational efficiency and meeting regulatory expectations. Developing orthogonal functional assays (primary cell based, SPR, imaging, alphaScreen) to perform structure-function studies and CQA assessment. Authoring IND, IMPD, and BLA. Serving Analytical and CMC lead roles.
Education
Virginia Commonwealth University School of Medicine
PhD, Cell and Molecular Biology
1997 — 2002
Zhengzhou University
Henan Medical University, MD, Hepatology
Skills
- Protein Chemistry
- Cell Biology
- Drug Development
- Bioanalysis
- Biopharmaceuticals
- Immunogenicity
- Good Laboratory Practice (Glp)
- Life Sciences
- Clinical Development
- Pharmacokinetics
- Biochemistry
- Glp
- Immunology
- Assay Development
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