Anthony Nieto Email & Phone Number

Oceanside, Ca, Us

Oceanside, Ca, Us

Foster City, Ca, Us

Perform kinetics and affinity studies for mAb intermediates, ADC, and glycovariants utilizing surface plasmon resonance (SPR) technology to study molecular interactions and Fc receptor binding. Study manufacturing process changes and investigate effects on KD. Attain and implement a fully automated plate handling system with MACSQuant 16 integration to generate a high-throughput flow-based screening platform supporting cell-based assay development activities. Support other Gilead sites and CROs with mirrored instrument setup, end-user training, and assay performance qualification.Develop, test, and optimize platform assay analysis templates in different software, including SoftMax Pro GxP, FlowJo, FACSDiva, GMP ELN, and Excel, to streamline data analysis and minimize variance between assays. Gather team feedback on templates and continually improve or encourage others to make adjustments and generate their own. Established auto-generated sample testing reports utilizing Excel PivotTables, query manager, macros, and VBA for applications to track and manage all projects and relevant testing. All reports are updated in real-time and track key metrics such as total FTE hours spent on sample testing, deadlines, on-time delivery (OTD), and ELN status.Create a novel primary cell-based ADCC assay to support comparability analyses for different manufacturing processes. Track and interpret donor to donor variance and analyze changes to ADCC activity via flow cytometry. Effectively communicate project background and assay development progress to the Biologics and Analytical Operations team by generating comprehensive presentations and scientific posters.Author test methods, standard operating procedures, assay development reports, excel data analysis templates, instrument operating manuals, new-hire training manuals, etc.

Foster City, Ca, Us

Support Biologics & Analytical Ops by conducting method development and optimization activities for various phase biologics to aid subsequent regulatory filings (focus on cell-based assay development).Performed QC testing in ELN/LIMS system, adhering strictly to cGMP and GDP to support critical in-house sample testing. Trained new analysts on QC sample testing, documentation, and reporting; worked directly with ELN management team to generate platform QC Potency Assay Template for all functional assays performed in GMP lab at Oceanside. Worked with project managers and vendors to acquire, install, and schedule training for new instruments such as flow cytometers, Incucytes, plate readers, cell isolation equipment, etc. Trained new analysts on proper operation and handling of equipment, reagents, and software. Set up semi-annual PMs and instructed end-users on appropriate routine maintenance and inventory supply management. Performed cell transfection, selection, and single-cell sorting or population sorting via FACS Aria to isolate our target populations. Cultured and passaged sorted cells, tested receptor expression by FACS, and generated RCBs for future use.Isolated PBMCs, Monocytes, and NK cells from either Leukopaks or whole blood using automated and manual isolation strategies. Designed and optimized complex primary cell-based assays that reflect MOA (ADCC, ADCP, etc.).Generated comprehensive cell banks (MCB, WCB, RCB, and eWCB) for various adherent and suspension cell lines using multi-layer flasks (2,5,10-layer), HyperStack, and G-Rex. Tested for Mycoplasma DNA via qPCR and utilized automated vial filling using the Sartorius Fill-it system for extensive cell bank generation. Employed various applications/software (SMP GxP, FlowJo, Python, Prism, JMP, Excel) to analyze large data sets to calculate relative potency, compile dose-response curves, trend historical data, and present technical presentations to the team.

Irvine, Ca, Us

Support the daily operations of the Biopharmaceutical Development Department by performing assigned large molecule testing in accordance with cGMP requirements, company policies, and procedures as directed by laboratory management.Perform method development, assay transfers, feasibility studies, qualification, and validations in accordance with cGMP requirements in support of the Biopharmaceutical Development Department. Perform drug stability and safety testing for biopharmaceutical drug products and substancesRead and understand test methodologies, study protocols, and SOPs to review or execute testing in compliance with policies and procedures.Assist technical project lead in communications with internal and external stakeholders during project-related discussions to provide project updates, present technical data, interpret results, and collaborate with team members to resolve technical issues.Record and review data in controlled notebooks, data sheets, and electronic systems in accordance with cGMP. Maintain clear, accurate, and traceable records to ensure compliance with GDP.Prepare technical documentation such as protocols, test methods, investigation summaries, test worksheets, and other technical reports in collaboration with other departments.Maintain laboratory and workspace cleanliness by adhering to the 5S method of organization.Assume ownership of assigned quality documentation such as exceptions, change controls, and CAPAs. Initiate documentation on schedule and ensure implementation of necessary actions

Laguna Hills, California, Us

Operated and maintained various class 4 ophthalmological lasers for use in various refractive eye procedures. Managed patient flow, coordination, and treatment for customized refractive eye surgeries. Worked with physicians, optometrists, and counselors in visual acuity data collection and the development of custom treatment. Communicated treatment plan and relay post-operative eye care to patients. Maintained and operated a wide range of technical/medical equipment. (Autorefractors, and handheld pachymeters, CustomView Wavescan, etc) Demonstrated a high level of detail orientation in a high-pressure, high-volume work environment

Campbell, California, Us