In this role I wear many hats and have developed into a jack of all trades in the startup and approval environment for a cell and gene therapy intermediate product. I currently work with genetic vector utilized in the transfection process in CAR-T cell therapy manufacturing. I perform Engineering and GMP runs which will be used to file for approval of the intermediate vector products to be used in CAR-T therapies. This process entails thaw of cells, which I then expand static incubation techniques using single-use materials. I then genetically transfect these cells and harvest the genetic material they produce. Throughout the engineering and GMP runs that I have participated in as a team lead, I have also written explanations and descriptions for our excursion events.In this position, I have developed training documentation for gowning processes, upstream cell expansion processes, and fill and finish processes. I have also, worked with my team to review documentation and push it to effective state, develop a training schedule, and spearhead a training material inventory tracker. I then worked with my team to train our manufacturing staff on our entire upstream process in the span of 5 months in order to have quick operator turn around and prepare for our GMP and Engineering runs.In addition to developing training documents for the gene manufacturing process, I have also written manufacturing batch records and standard operating procedures for portions of our upstream manufacturing processes. This involved leveraging information from tech-transfers from other internal company sites and contractors.

In this position, I worked in the production of the first commercially approved gene-based therapy (Zolgensma) used for treatment of Spinal Muscular Atrophy in young children and infants.My primary responsibility was to oversee cellular expansion in flask incubations and single-use iCELLis Bioreactor units. This included genetic transduction and Tangential Flow Filtration for initial product purification.Through this role I have become more experienced in working in clean room environments ranging from ISO-7 (Grade B) to ISO-5 (Grade A). I was also trusted and designated as a trainer for Cell-Expansion Processes and Nova Bioprofile Cell Culture Analyzer.I helped lead the team by creating our daily team schedule to ensure that daily tasks were completed efficiently and correctly. This entailed identifying strengths of team-members and grouping associates together to build functional and successful teams. In this role I also utilized SCADA software system for tracking of equipment parameters such as incubator status, Tangential Flow Filtration Skid, and iCELLis bioreactor’s parameters.

In this role I work in GMP manufacturing of patient derived clinical and commercial cellular immunotherapy products. I work in the manufacturing of patient specific CAR-T cells for the purpose of treating B-cell lymphomas. My role primarily involves overseeing the manufacturing process on individual patient which entails everything from thaw of patient material, viral transduction of target cells, and incubation- to the fill and finish of the final product. The crucial, aseptic nature of this work requires gowning into and working in ISO-8, ISO-7, and ISO-5 areas is necessary. The work that I perform is done with aseptic technique, utilizing a bio-safety cabinet, and requires me to perform viable and non-viable environmental monitoring throughout the process. I have also taken on additional responsibilities by performing media production and designated to train new personnel in the production of media. Furthermore, I have been trusted as an Aseptic Operator Qualification trainer, through which I assess the aseptic technique of personnel in order to qualify them to work in an ISO-5 environment.Outside of the lab, I have taken initiative to become a certified investigator and write investigation reports for deviations and process excursions utilizing Trackwise/AQWA software. I also perform batch record review to check the work of peers for correct adherence to cGMP standards and ensure SOPS were followed.Every day this position brings a great sense of ownership and responsibility, as I am working in international personalized treatment of people who were diagnosed with leukemia and have exhausted other options of treatment. My work has a tremendous impact on these patients' lives.

In this role, I worked in GMP manufacturing of patient derived clinical and commercial cellular immunotherapy products. I worked in the manufacturing of patient specific CAR-T cells for the purpose of treating B-cell lymphomas. My role primarily involved overseeing the manufacturing process on individual patient which entails everything from thaw of patient material, viral transduction of target cells, and incubation- to the fill and finish of the final product. The crucial, aseptic nature of this work required gowning into and working in ISO-8, ISO-7, and ISO-5 areas is necessary. The work that I performed was done with aseptic technique, utilizing a bio-safety cabinet, and required me to perform viable and non-viable environmental monitoring throughout the process.

In this role, I worked in GMP manufacturing of patient derived clinical and commercial cellular immunotherapy products. I worked in the manufacturing of patient specific CAR-T cells for the purpose of treating B-cell lymphomas. My role primarily involved overseeing the manufacturing process on individual patient which entails everything from thaw of patient material, viral transduction of target cells, and incubation- to the fill and finish of the final product. The crucial, aseptic nature of this work required gowning into and working in ISO-8, ISO-7, and ISO-5 areas is necessary. The work that I performed was done with aseptic technique, utilizing a bio-safety cabinet, and required me to perform viable and non-viable environmental monitoring throughout the process.

In this position, I monitored and inspected microbiological testing processes and data for pharmaceutical and medical device products for conformance under strict regulation (USP, JP, EP) through the use of guidelines and compendia. I monitored microbiological testing including microbiological enumeration, endotoxin, bioburden, and sterility through laboratory walk-throughs and data review of paper and electronic records. I also ensured correct reporting and information delivery to customers. In this position precision and attention to detail were crucial. Multi-tasking was a regular part of the position, and it helped me become a very flexible and focused person.

As a surveillance lab intern, I was responsible for genus and species identification of mosquitoes in different stages of development, performing disease vector testing assays, advising technicians in the laboratory, and surveying mosquito populations by collection of samples through field work. Acting as a lead intern, I was responsible for assuring quality work, presentations, and at times supervising the laboratory. In this position, I also managed large data sets and communicate results to different customers served by the company. Special attention was directed to safety and making sure research methods were effective and performed correctly. The position allowed for me to work in the ever broadening field of environmental science and combat a public health threat.