Ken Ngim
Executive Director, Small Molecule Analytical @Arcus Biosciences
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WORK HISTORY
Executive Director, Small Molecule Analytical @Arcus Biosciences
Hayward, CA, US
EDUCATION
University of California, Davis
B.S., Environmental Toxicology
University of California, Davis
Ph.D., Agricultural & Environmental Chemistry (Ph.D., 1999)
ABOUT KEN NGIM
Background in both analytical development and quality control, with knowledge of roles and responsibilities of each in enabling drug development and manufacturing. • Regulatory filing authorship from first in man to commercialization (IND, IMPD, NDA, end of Phase 2 and pre-NDA briefing documents, regulatory responses).• Understanding of phase-appropriate rigor in testing, SOPs, laboratory infrastructure, specification development and manufacturing.• Fundamental and practical understanding of most techniques and instrumentation used in testing.• Management of CMO/CRO and in-house analytical testing resources. • Commitment to ensuring that data is scientifically sound and able to withstand regulatory scrutiny.• Departmental and CMC team leadership and management. • Management of bachelor’s to doctorate level staff, including mentorship and professional development.• Proven achiever and problem-solver at every career level.Author or co-author of 16 publications, including:• K.K. Ngim, J. Zynger and B. Downey. “Determination of Residual Monoethanolamine in the Presence of a Secondary Amine Active Pharmaceutical Ingredient by FDAA Derivatization and HPLC-UV/vis”. J. Chromatogr. Sci, 2007, 45(3):126-130.• K.K. Ngim, Z. Gu and T. Catalano. “Characterization and Resolution of Reversed Phase Chromatography Failure Attributed to Sulfobutylether-beta-cyclodextrin”. J. Pharm. Biomed. Anal, 2009, 49(3):660-669.• Q.M. Zhong, K.K. Ngim, M. Sun, J. Li, A. Deese and N. Chetwyn. “Strategies for the Analysis of Highly Reactive Aryl Pinacolboronate Esters”. J. Chromatogr. A, 2012, K.K. Ngim, Q.M. Zhong, K. Mistry and N. Chetwyn. “Effect of Sulfobutyl Ether beta-Cyclodextrin Modifier on Selectivity of Reversed Phase HPLC Separations”. J. Liq. Chromatogr. R. T, 2012, 35(20):28••••59.• Q.M. Zhong, S. Stowers, N. Segraves, K.K. Ngim, K. Zhang, T. Bostick, A. Deese and N. Chetwyn. “Degradation of A Pharmaceutical in HPLC Grade Methanol Containing Trace Level Formaldehyde”. Pharm. Dev. Technol, 2013, 18(4):877-882.
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