QUALIFICATION: Biochemistry Ph.D with >9 years of industrial experience in biopharmaceutical company In-depth understanding of downstream process operations (chromatography and filtration) of biologics A proven track record of purifying multiple modalities of biologics drugs Process development with high-throughput process development and statistical design of experiments (DoE) Process characterization and technology transfer into industrial GMP environment Authoring CMC documents for IND and BLA regulatory filings Managing/mentoring scientists in a laboratory setting SKILLS: Nucleic acid chemistry, enzymatic reactions, PCR, and plasmid processing in vitro transcription and mRNA purification technologies ÄKTA systems, TECAN system, and PendoTECH System Affinity, ionic exchange, hydrophobic, and mixed mode chromatography Depth filtration, microfiltration, nanofiltration, sterile filtration, and ultrafiltration SEC, PAGE, DLS, DSF/DSC, ITC, ELISA, Northern/Southern/Western blots JMP, @RISK, Geneious, RNA structure, PyMol, VectorNTI, Spotfire, ImageQuant, Image Lab
Director at Ultragenyx Pharmaceutical Inc.
Doctor of Philosophy - PhD, Biochemistry