San Diego, California, United States
Experienced leader in Preclinical Manufacturing of gene therapy products with a focus on AAV and LVV programs at 200L scale for drug studies. Proven expertise in overseeing tech transfer to GMP, cross training, inventory management, analytical coordination and change management. Effective communicator in a highly matrixed environment across shareholders, project managers and technical leads, ensuring program success despite challenges.
Managed the personnel in the PCM Upstream team to manufacture Adeno-Associated Virus (AAV) and Lentiviral Vector (LVV) product to support the development, scale up, tech transfer of therapy of neurological genetic diseases to support program needs. Responsible for the scheduling of the process to meet program deadlines, communicating with supply chain to ensure the necessary materials were on site and to find alternate materials when necessary to prevent the delay of the production schedule.
The Process Development team works to drive the advancement of Adeno-Associated Virus (AAV) and Lentiviral Vector (LVV) platforms and manage the development, scale-up, tech transfer, optimization and characterization of process for the clinical and commercial manufacturing of both new and licensed Novartis gene therapies. Responsible for working in teams to develop improvements in the manufacturing process, explore new technology, test new reagents and produce pre-clinical material for toxicology studies and to support the research groups at Novartis Gene Therapies, San Diego. While in this role, I also served as the TRD Safety Chair for San Diego, responsible for leading in a matrix organization to facilitate safety discussions with different Novartis TRD groups across to improve the safety practices at our site, communicating with HSE to ensure that our safety practices are compliant with relevant safety regulations and coordinating with other Novartis TRD sites to ensure that our safety practices are aligned.
Responsible for working in teams to develop improvements in the manufacturing process, explore new technology, test new reagents and produce pre-clinical material for toxicology studies and to support the research groups at Novartis Gene Therapies, San Diego.
Maintained Crithidia and HeLa cell lines and purified human blood for production for use in the manufacturing process, set up the manufacturing equipment, troubleshot issues and inspected the final product to ensure product quality. Additionally, was responsible for tracking the inventory of raw materials, the validation of new equipment, the communication of the monthly metric to the manufacturing team and point of contact with the Environmental Health and Safety (EH&S) Manager
Responsible for general support activities of a Good Manufacturing Process (GMP) testing laboratory. While in this role I used aseptic technique to collect environmental samples from GMP facilities and clean room environments and supported the quality control sample management process.
Professor Stroeve Nanoparticle Group Worked in a team to tune the release of proteins from mesoporous silica through the functionalization of the mesoporous silica using polyelectrolytes for the purpose of target drug delivery. While in this group, I was involved in each step of the experimental process, from synthesizing expanded pore nanoparticles, functionalizing the surface and pore walls of the synthesized mesoporous silica, loading the cargo drug, performing release experiments, data analysis and presentations on the experimental results. I also improved efficiency of the standard process for the release experiments at human body temperature, reducing people to conduct experiments from three people to one person.
Professor Stroeve Core Shell Group Worked individually and in teams to study the release of Methyl Blue dye from super-paramagnetic Iron Oxide Nanoparticles (SPION) and Mesoporous Silica in a lipid bilayer with plurionic for target drug delivery. This required the use of equipment such as a centrifuge, drying stove, calcination stove, UV-Vis spectrometer and sonication bath and tip. Required running reactions under N2 atmosphere and degasifying DI water, and involved training new research assistants to perform the synthesis and release experiment. Ultimately, the results published in the Journal of Colloids and Surfaces B: Biointerfaces October 1, 2014 (Volume 122, Pages 818-822) and I presented the results as a poster presenter at the “Challenges in Nanoscience” Conference hosted by the Royal Society of Chemistry.