Zhi Chen
Associate Scientific Director at Bristol-Myers Squibb
- Role
- Associate Scientific Director at Bristol Myers Squibb
- Location
- Union, NJ, US
- LinkedIn followers
- 500 followers
About Zhi Chen
Seventeen years’ working experience in the biopharmaceutical industry from development to manufacturing. Drug product and analytical development lead supporting CMC from pre-clinical to commercial for both biologics and small molecules. Excellent working knowledge of cGMP, FDA, EMEA and ICH guidelines. Experience with writing CMC documents for regulatory fillings (IND, NDA and BLA). Strong problem-solving and troubleshooting skills, effective communication, presentation and organizational skills. Energetic scientist with a solid publication record.
Experience
Associate Scientific Director
Aug 2020 — Present
Sterile Product DevelopmentDrug Product Development
Education
Xiamen University
B.S., Chemistry
1996 — 2000
University of Pittsburgh
Ph.D., Analytical Chemistry
2001 — 2007
Skills
- Hplc
- Glycosylation
- R&D
- Protein Chromatography
- Validation
- Mass Spectrometry
- Quality by Design
- Tga
- Quality Assurance
- Peptides
- Size Exclusion
- Residuals
- Formulation
- Lc-Ms
- Dissolution
- Hcp
- Gc/Ms
- Cgmp
- Chromatography
- Ich Guidelines
- Protein Purification
- Fmea
- Particle Size Analysis
- Design of Experiments
- Chemistry
- Amino Acids
- Gmp
- Karl Fisher
- Protein Chemistry
- Ce-Sds
- Uv-Vis
- Monoclonal Antibodies
- Uv/Vis
- Pharmaceutical Industry
- Fda
- Ion Exchange
- Technology Transfer
- Drug Development
- Analytical Chemistry
- Cief
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