Radiance D. Thompson

• Develop, plan and oversee cell line, DS and DP development programs, including plan of raw and consumable materials according to budgets and timelines
• Work with US based CROs and CDMOs for stem cell characterization, cell line development, according to non-GMP and cGMP in support of DS and DP Phase1/2/3 clinical programs 
• Present experimental findings to local and international stake holders including Analytical Science, Quality Assurance, Research and Development and Manufacturing
• Design of experiments using murine and human iPSCs and human ESCs for in vitro studies to optimize cell culture processes and ensure progression toward CMC project timelines 
• Prepare, review and edit cGMP batch records and quality documents for biologics 
• Design of experiments and establishing process control strategies with iPSC mammalian cell lines in 2D adherent and 3D cell suspension cultures in T-flasks, shake flasks, 1L and 10L bioreactors  
• Facilitate pre-pivotal stage 1L bioreactor experiments with 3D iPSC mammalian stem cell cultures to meet upstream experimental goals of improving mass and proliferation profiles at the 1L and 10L scale 
• Collaboration with software and validation engineers to implement in-house digital stem cell inventory system to improve traceability and data accessibility of stem cell lines, drug substances (DS) and drug products (DP) at local and international company sites
• Cross-functional collaboration with formulation engineers to design 3D printed standardized instruments to improve 3D shake flask, 1L bioreactor and 10L bioreactor stem cell culture processes for future use in GMP facilities 
• Apply PAT, QbD principles and phase appropriate approach to adjust process conditions using an in-vitro spheroid stem cell model 
• Identify drug substance and drug product purity, potency and impurity targets using 6-color FACS analysis

• Collaborating with cross-functional teams of 3-10 people from Materials Science and Technology (MS&T), Quality Assurance (QA), Quality Control (QC), Manufacturing and regulatory departments to lead CMC related programs that included clinical documentation, provide technical support to transfer teams, author training materials and create protocol amendments for improving projects
• Conduct site monitoring and experiments to optimize process conditions, reduce COGs, increase operational workflows, improve manufacturability timelines of PBMCS, CAR T and T-cell therapy DS and DP to target B-cell Lymphoma and Acute Lymphoblastic Leukemic 
• Executing daily operations to ensure high quality immune activation and safety of CAR T and T-cell in-process material and drug products according to SOP, cGMP, GDP, GLP, GCP, Data Integrity, FDA and ICH regulatory guidelines in a BSL-2 sterile environment
• Lead cross-functional programs with MS&T, QA and Process and Development (P&D) Departments to analyze data trends that include deviation identification, root cause analysis (RCA) and corrective and preventative actions (CAPAs) when applicable in compliance with FDA and EMA regulations 
• Process validation in preparation for IND filing, BLA filing and commercial product release 
• Upkeep of laboratory equipment which includes Preventative Maintenance (PM), Calibration, Executing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to increase uptime of equipment and support site Key Performance Indicators (KPIs) during ramp up of clinical studies and commercial production for Yescarta and Tecartus

• Contribute to selection of drug candidates for Lou Gehrig's disease (ALS) using LC-MS, HTP-SELEX screening, SDS Page and Sanger Sequencing to create DNA (aptamer) library 
• Quantitative and quanlitative analysis of small target molecules, proteins and DNA using UV Spectrophotometry and wet chemistry techniques
• Investigate Middle East Respiratory Syndrome coronavirus binding domain and the multi-subunit DNA-binding oncogenic zinc-finger protein structure GLI1 
• Attend and present posters at local, state and national scientific conferences

• Performed in-vitro diagnostic (IVD) drug testing for high volumes of urine samples using PCR
• Specimen accession, sample sorting and data entry of patient information in a Laboratory Information Management System (LIMS) according to HIPAA guidelines in a fast-paced clinical environment

• Maintain upkeep of laboratory equipment, formulation and autoclaving of media solutions, antibiotic dilutions and small molecule solutions
• Application of problem-solving, effective communication and bench work practices to maintain fetal bovine cell lines for Herpes Simplex Virus-1 Research
• Maintain detailed laboratory notebook that includes daily reports of methods, equipment and materials used, and tracking and ordering supply weekly

• Assisting nurses with delivering blood and urine specimens, transportation of patients, delivering bedding, food and chemo-treatment supplies to the nurse's station, witnessing biopsies and other surgical procedures while monitoring cancer patients 

Interning for Wolfgang Puck - worked at Grammy and Academy Awards, catered for celebrity dinner parties

California Alliance Minority Program Research Grant $2000

UCI Research Fellowship Award $5000