Radiance D. Thompson

• Constructed formulation studies establishing drug substance and drug product stability profiles for 20+ potential drug products, ensuring compatibility with specialized container-closure systems for cryogenic storage
• Successfully managed technology transfer to 3 CDMOs for stem cell manufacturing processes, ensuring 100% knowledge transfer accuracy and maintaining cGMP compliance across all sites
• Presented experimental findings to 30+ stakeholders across international sites, securing $3M+ in continued project funding 
• Designed 15+ DOE studies optimizing iPSC and ESC culture processes, accelerating CMC timeline progression by 20%
• Established 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  
• Facilitated 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 
• Collaborated 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 and drug products at local and international company sites
• Developed and optimized cryopreservation protocols for 20+ drug substance and drug products including iPSCs and ESCs, achieving average of 85%+ post-thaw viability and reducing freeze-thaw cycle time by 30%
• Authored 25+ regulatory documents including batch records, SOPs, PFDs and PFMEAS
• Developed comprehensive stability testing strategies for 20+ potential cell therapy drug products, establishing shelf-life specifications that supported regulatory submissions
• Conducted root cause investigations for 10+ complex manufacturing deviations, implementing corrective actions that prevented recurrence in 95% of cases
• Developed PFDs, PFMEAs and procedures to present to internal and external stakeholders to assess process variability, capability and formulation development for cell products
• Interfaced with clinical operations teams to develop standardized cell product handling procedures, ensuring reproducible administration protocols across 5+ clinical sites
• Aseptically trained and mentored 10+ engineers and technical staff, with 90% of mentees receiving promotions or expanded responsibilities within 18 months
• Drove stability strategy and statistical process monitoring for 20+ critical process parameters of cell line profiles, establishing testing protocols that decreased process optimization time by 25%, improved drug product quality and decreased batch-to-batch variability by 40%

• Collaborated with 8+ cross-functional teams to integrate drug product processes, resulting in 90% on-time delivery of critical project milestones
• Established process control and risk management frameworks that reduced process deviations by 35% and improved overall manufacturing compliance scores
• Conducted site monitoring and experiments to optimize process conditions, reduce COGs, increase operational workflows, reduced manufacturability timelines for CAR T and T-cell therapies by 35%, decreasing time-to-patient delivery and increasing chances of survival
• Executed 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
• Led cross-functional programs with MS&T, QA and Process Development Departments to analyze data trends that include deviation identification, change controls, root cause analysis (RCA) and corrective and preventative actions (CAPAs) when applicable in compliance with FDA and EMA regulations
• Validated processes in preparation for IND filing, BLA filing and commercial product release
• Served as floor-level support and technical interface to support the process team during formulation, filling and visible inspection
• Led troubleshooting initiatives resolving 10+ critical operational issues, reducing equipment downtime by 30%
• Developed scope for $2M+ in capital projects, delivering 100% under budget 
• Oversaw cross-functional risk assessments identifying 15+ process improvement opportunities, resulting in $500K annual cost savings
• Identified and drove continuous improvement on procedural changes, projects, upgrades to equipment use as it pertains to process procedures
• Led scale-up manufacturing studies from lab to commercial scale, optimizing fill-finish processes that reduced cold chain logistics costs by 25% while maintaining product integrity
• Established predictive maintenance protocols for critical equipment, increasing overall equipment effectiveness to 95%+

• Contributed to selection of drug candidates for Lou Gehrig's disease (ALS) using LC-MS, HTP-SELEX screening, SDS Page and Sanger Sequencing, UV Spectrophotometry to create DNA (aptamer) library
• Investigated Middle East Respiratory Syndrome coronavirus binding domain and the multi-subunit DNA-binding oncogenic zinc-finger protein structure GLI1
• Attended and presented 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

• Application of problem-solving, effective communication and bench work practices to maintain fetal bovine cell lines for Herpes Simplex Virus-1 Research
• Maintained 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