Current role as Senior Scientist.
Responsible for developing and validating variety of analytical methods, and transferring protocols of pharma and biopharma compounds. Performing routine and non-routine testing for drug products and substances for product release and stability studies under cGMP compliance, including assay and impurity, dissolution and residual solvents, etc.
Acting as project leader on multiple projects, interacting with clients, reviewing and evaluating data, while writing reports and protocols. Preparing, reviewing, interpreting, and analyzing internal technical documents, including data for technical, quality and compliance to protocols, methods, SOPs, client criteria, OOS investigation and CAPAs, maintaining high standard quality system, and meeting cGMP requirements.
Vast experience in method development, validation and transfer, HPLC and UPLC (with small molecules and troubleshooting but also running HPLC and GCMS for 2 years during graduate studies), ion chromatography and large molecules characterization with capillary electrophoresis, and images capillary electrophoresis. Broad analytical experience along with full understanding of cGMP/cGLP laboratory requirements, ICH guidelines, USP requirements, and FDA regulations.
Received Ph.D. in Chemical Engineering from Washington State University and Bachelor of Engineering in Chemical Engineering (full scholarship) from Sarawak Malaysian University.
Back to the top candidate list