Kyle Gomes Email & Phone Number

Us

Philadelphia, Pa, Us

• Performing experiments in the development, optimization, characterization, and scale-up of recombinant adeno-associated viral vector (rAAV) production processes in suspension cell culture systems, with a focus on stirred tank bioreactor production up to and > 200L• Conducting rAAV production studies in shake flasks and stirred tank bioreactors from AMBR to commercial pilot scale• Assisting in addressing production process challenges by applying cross-functional knowledge with an understanding of industry best operating procedures• Analyzing and interpreting experimental results; suggesting changes or additional experiments to improve the robustness and/or reproducibility of the production process• Participating in discussions regarding the troubleshooting of production processes and/or investigations; performing supporting studies as needed• Contributing to the evaluation and implementation of new technology development• Participating in Technology Transfer from process development to manufacturing sites; assisting in training manufacturing staff as needed• Authoring and executing protocols, assembling data and drafting appropriate technical documentation, which may include, but is not limited to SOPs and Process Development Reports• Maintaining an accurate laboratory notebook following ALCOA+ principles• Participate on Pipeline and/or Technology Platform project teams as a contributing member

Philadelphia, Pa, Us

• Performing experiments in the development, optimization, characterization, and scale-up of recombinant adeno-associated viral vector (rAAV) production processes in suspension cell culture systems, with a focus on stirred tank bioreactor production up to and > 200L• Conducting rAAV production studies in shake flasks and stirred tank bioreactors from AMBR to commercial pilot scale• Analyzing and interpreting experimental results; suggesting changes or additional experiments to improve the robustness and/or reproducibility of the production process• Participating in Technology Transfer from process development to manufacturing sites; assisting in training manufacturing staff as needed• Authoring and executing protocols, assembling data and drafting appropriate technical documentation, which may include, but is not limited to SOPs and Process Development Reports• Maintaining an accurate laboratory notebook following ALCOA+ principles• Participate on Pipeline and/or Technology Platform project teams as a contributing member

Philadelphia, Pa, Us

• Culturing mammalian cells for viral production in shake flasks, spinner flasks, spin tubes and/or benchtop bioreactors up to 40L• Performing experiments in the development, optimization and scale-up of production processes. • Preparing and reviewing process development protocols, data analysis summaries, technical reports, and other relevant process documentation.• Optimization of transfection and transduction protocols• Maintaining an accurate laboratory notebook.• Ensuring work conforms to applicable quality and safety standards.• Participating in the technology transfer from process development to manufacturing sites (as needed).• Successful training of colleagues on various experimental assays

Shanghai, Shanghai, Cn

• Responsible for the manufacturing of clinical and commercial Cell and Gene Therapy products• Adhering to current Good Manufacturing Practices set by CFR 21 and standard operating procedures • Assisting in the startup, validation efforts for the manufacturing facility and equipment, and product changeovers • Communicating across multiple departments and clients to achieve the overall goals and objectives• Provide operational and general guidance to junior staff while serving as a mentor in manufacturing techniques and operations • Investigating nonconforming events while conducting root cause analysis to put forth a corrective and preventive action plan to prevent similar events from occurring again. Using problem solving skills and knowledge of FDA regulations to resolve and make recommendations to deviations and nonconforming events• Authoring new standard operating procedures, batch records, change controls, product specification sheets, and solution preparation records while continuing to make safety improvements

New Castle, Delaware, Us

• Improved bacterial strain and fermentation development to produce acetone and ethanol at higher titer and yield by preparing multiple growth medias and antibiotics for microbial lab • Managed multiple reactors while ensuring the sterility and functionality of equipment used in the lab• Developed alongside lead scientist different experiments to test variables of interest in Clostridium cell growth. Increased ethanol production by a factor of 20 and determined the ideal environment for cell growth and ethanol production• Communicated with lead scientist and other employees a set of experiments that tested two variables at the same time to determine the joint effect. Effectively reduced the lag phase of bacteria and reduced risk of contamination • Documented and took fermentation samples for analysis to track chemical profiles of each reactor through the use HPLC and GC machines. Determined mutated cell strains that were sampled and frozen for future experiments • Created relief lines for each reactor. Relief valves ensured a safe environment for pressurized lab experiments

Newark, De, Us

• Maintained and grew brain endothelial cells with proper lab technique. Conducted experiments to determine optimal growth for cells that would later become the basis for future experiments • Developed a method to culture brain endothelial cells in three dimensions. By doing so, created an environment that simulated a brain and was able to grow cells and form a capillary tube • Administered various controlled experiments to determine the most efficient way for cell lysis. Using a protocol, conducted a Western Blot and determine proteins produced from cells thus conforming brain endothelial growth • Linked better understanding of brain endothelial cells to the treatment of Alzheimer’s disease. Tested the uptake of green fluorescent antibodies, then later calculated mass balance and was able to account for 98% of antibodies. Tested same system with cytokines and observed weaken strength of b.End3 cells thus allowing absorption of antibodies. Created a model for b.End3 cells that simulated the effects of Alzheimer’s disease