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 providing analytical characterization support for drug product formulation and process development activities. Part of the drug product development organization and provide guidance and support of drug product control strategy for drug candidates across multiple stages of development.

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• Manages project timelines and scheduling• Manages budget and revenue for projects• Prepares and reviews scientific training materials• Trains analysts/junior scientists• Serves as analytical subject matter expert (SME)• Control of the lab equipment and supply inventory. • Coordinate the replacement or repair of faulty equipment and supplies with vendors• Scheduling of instrument calibrations and preventative maintenance as per schedule.

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 biologic molecules (monoclonal antibodies, therapeutic proteins)• 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 Spectrometry (LC/MS/MS)• 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 models. Performed role as lead scientist in all biochemical related studies. • 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• Extremely adept at operations and maintenance of LC and LC/MS equipment for use in various research protocols• Led method development for the analysis and measurement of various molecular species found within ocular tissues• Trained and supervised the work of Research Associates and university student interns

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.