Cui Ye

Background

About Cui Ye

Highly motivated, creative and collaborative PhD biochemist with 6+ years of postdoc and industry experience in protein characterization, assay development, project management and QA in GLP environment. Experience in protein (e.g. antibody) characterization and purification: HPLC, SEC, ELISA, Spectrometry, western blot, gel electrophoresis, etc. Expertise in development, optimization, validation and transfer of high-throughput immunoassays and bioassays across multiple platforms and technologies: ELISA, AlphaScreen, cell-based, potency, cytotoxicity, report assays, etc. Good understanding of cell flow cytometry (FACS). Hands-on experience in mammalian cell culture, cell functional assays, nucleic acid extraction, PCR, qPCR. Worked in a GLP environment. Thorough understanding of the FDA, EMA and ICH regulatory guidance related to the validation of bioanalytical assays. Demonstrated ability to prepare SOPs, summarize results, and write technical reports in support. Experience in managing/working with CROs; demonstrated ability to identify, negotiate, and oversee outsourced services with vendors. Experience with process development using FPLC systems (e.g. AKTA). Familiar with automated or semi-automated instrumentation (e.g. Agilent Bravo, BioTek Plate Washer/Dispenser). High competence in common software and data analysis packages (e.g. SoftMax Pro, GraphPad Prism, Excel). Knowledge and experience with a broad array of technologies; ability to understand project goals at an advanced level, select appropriate methods/techniques and independently plan and execute experiments that support nonroutine research activities and project goals. Able to multitask and work on diverse projects at the same time; able to work under minimal supervision on projects with moderate to complex scopes, as well as being a good team player. Strong verbal/written communication skills; excellent organization and data/project management skills.