Robert Nguyen Email and Phone Number

• Work hands-on to develop and validate Pharacokinetics, Anti-drug Associations, Immunogenicity and Neutralizing antibody immunoassays (ELISA, MSD, etc.).• Provide scientific expertise and oversight in assay development, validation and sample analysis.• Troubleshoot problems and advise lab team, as needed. Oversee laboratory equipment use and maintenance.• Develop and write bioanalytical test methods as necessary. Review developmental, validation and sample data• Operate laboratory equipment and perform routine maintenance as required.• Prepare laboratory solutions, reagents, and bio-conjugated materials following standardized procedures.• Conduct lab operations according to applicable SOPs, test methods and FDA/GLP regulatory requirements.• Follow good documentation practices; keep lab records in a consistent, compliant and accurate manner. Record documentation per appropriate formats (e.g. controlled form, notebook, logbook)• Ensure routine maintenance, scheduled performance verification testing, documentation and training for assigned equipment is conducted as required per applicable SOPs.• Assist in inventory maintenance, monitoring, ordering and receiving of lab materials.

• Provides direction to multi-department personnel to achieve operational and technical objectives including workflow design, service quality, financial performance, regulatory compliance, personnel management, and integration of intra and inter-departmental activities.• Experienced in conformance of USP and FDA cGMP regulations.• Statistical data analysis and trending to support sample reviews, regulatory submissions, and various inquiries including Out-of-Trend (OOT) and Out-of-Specification (OOS) investigations.• Validate, operate, and analyze various chemical and microbiological instruments/assays.

• Ensure Raw Materials and Finished Products complete testing schedule.• Chemical assay of raw materials and finished products; HPLC, Dissolution, FT-IR, Titrations, etc. • Support Stability Program, Process Improvement, Batch Release, and Product investigations

• Research, Training and Development Lab Analyst: includes all tasks performed at Laboratory Technician level.• Primary data generator, recorder and calculator, expertise, nonconformance Writing & Compendium of Analytical Methodology including: AOAC, USP, ISO, BAM, NELAC, SSOP. utilization of Task Management Software: LIMS • Performing microbiological assays for identification and analysis of pathogenic organisms: includes PCR Testing, ELISA, Gram Staining Procedure, Bacterial API Interpretation, reagents and culture media preparation.