Tam Bui Email & Phone Number

A member of Analytical CMC group that serves as a drug product analytical lead who drives analytical strategy and support for small molecule drug product development activities. Provide leadership support as manager of a team of analytical development scientists and as an analytical matrix team lead to support analytical method development as well as.

• Part of the CMC Development Team that execute product development activities related to supporting of late stage candidates for successful commercial product launches.Essential Responsibilities:
• Serves as lead scientist on assay development, validation, and sample analysis project for support of CMC characterization, stability and release testing
• Follows ICH guidelines for method validation and sample analysis
• Writes plans and reports for validation and sample analysis
• Responsible for prompt identification, submission, notification, and review of deviations
• Manage and troubleshoot CRO testing sites

• Perform in vivo and in vitro studies to support pre-clinical research in the field of ophthalmology and pathogenesis of dermatological diseases.
• Molecular Biology Research: o Execute and develop cell culture process (mammalian expression) and fermentation process (microbial expression) o Assist with the development and purification procedures for a variety of.
• Screening of therapeutics in age‐related macular degeneration and psoriasis
• Tissue collection, data collection, microscopy, immunohistochemistry (IHC), HRA/OCT, and animal surgeries
• Conduct molecular biology research projects in collaboration with staff scientists.o Gene expression analysis such as Westerns, rtPCR, and ELISAo Grow and maintain cell culture lines
• Routinely responsible for ordering supplies, organizing studies, assisting with experimental protocols, data analysis, and record keeping

• Performed complex physical, chemical, and microbiological analyses on water, wastewater, and related samples.
• Followed Good laboratory practices (GLP) on quality control and quality assurance
• Responsible for operating, troubleshooting, and maintaining lab instruments such as Gas Chromatography /Mass Spectrometry (GC/MS), High Performance Liquid Chromatography (HPLC) and Liquid Chromatography Tandem Mass.
• Used LC/MS/MS and GC/MS systems to support Unregulated Contaminant Monitoring Regulation (UCMR3) and other emerging contaminant monitoring programs in addition to routine EPA 500 series methods for drinking water
• Used networked LIMS system for reporting water quality data
• Coordinated and ordered high grade gases and liquid nitrogen requirements for the lab

• Researched the mechanism of action of a Phase II proof of concept trial for a chemo preventive drug to treat age related macular degeneration and skin cancer.
• Analyzed clinical data and ongoing results
• Responsible for the day to day operations of the biochemistry laboratory
• Maintained and stocked laboratory equipment and supplies
• Developed new separation technologies for the analysis of Vitamin A derivatives, lipids, and small molecule compounds.
• Extensive experience in chromatographic techniques involving HPLC, solid phase extraction and mass spectroscopy

• Developed pharmacotherapies in a translational research laboratory to treat human retinal diseases. Helped to design small molecule therapeutics used in vivo and in vitro to establish preclinical efficacy in animal.
• Responsible for the day to day operations of the biochemistry laboratory and animal vivarium
• Laboratory safety officer and assistant to radiation safety officer
• Proficient in animal handling, husbandry and manipulation of transgenic animal models
• In-vivo analysis (topical and systemic administration) of test compound efficacy in animal models of human retinal disease
• Extensive experience in chromatographic techniques involving high performance liquid chromatography, thin layer chromatography and solid phase extraction

Responsible for developing suitable liquid or lyophilized formulations for protein pharmaceuticals.

Assist with a primary investigator in academic research in the field of vision biology.

Responsible for writing protocols and completing viral validation studies under GMP/GLP conditions in the department of Analytical Services. Involved with quality control and project management.

Worked under the supervision of a primary investigator on multiple projects involving tissue culture, ELISAs, blood work, and maintaining mice colonies in pursuit of a cure for lupus.