As part of the Lonza MSAT team I will be helping to provide advanced bioprocessing production capacity for companies creating life changing therapeutics around the world.

Within Thermo Fisher Scientific's Viral Vector Services division I am part of the Manufacturing Science and Technology (MSAT) group that drives the tech transfer of viral vector gene therapy bioprocesses. The primary objective of our tech transfers is to bring unique client based bioprocesses to cGMP production scale for supporting clinical trial execution and eventual commercialization of groundbreaking gene therapies. The responsibility of MSAT is to lead tech transfer projects as scientific subject matter experts and to collaborate with cross functional teams that include members of the quality, engineering, process development, manufacturing and process characterization groups. As a Scientist on the MSAT team communication is critically important whether it is communicating directly with our clients or internal teams. A tech transfer can originate externally (from clients) or internally from our process development group in Alachua Florida. As a subject matter expert it is my responsibility to develop and author detailed process descriptions (DPD) and facility fit, gap/risk assessments for the incoming viral vector production processes. The technical detail of these documents allows me to coordinate everything from equipment, material and consumable selection to facilitating Batch Record generation to suggesting and implementing process improvements/adaptations that will allow for cGMP compliant execution of these processes at commercial scale. To drive process improvements and adaptations I have been responsible for designing, authoring and executing numerous study protocols and technical reports. I am also part of the team responsible for bringing online a state-of-the-art process establishment lab space in our new facility located in Lexington Massachusetts. I feel very fortunate to be part of an MSAT group that is so motivated and dedicated to enabling the proliferation of groundbreaking, life changing gene therapies to patients around the world.

At Brammer Bio I work as part of the Manufacturing, Science and Technology team in Cambridge, Ma. Our primary initiative is to to develop client specific bioprocessing projects for eventual scale up and tech transfer to production level runs in our GMP viral vector suites. Responsibilities as a scientist on the MST team involve everything from designing detailed process parameters for viral vector production, obtaining the proper materials and equipment for carrying out all runs and experiments necessary, engineering process flows compatible with tech transfer to GMP processing and interfacing with clients to collaborate on their project's process development.

At Sartorius I worked managing accounts, growing relationships, problem solving and collaborating with biotechnology and pharmaceutical companies in the American Northeast. At Sartorius I wasresponsible for knowing and presenting an extensive portfolio of bioprocessing solutions ranging from cell line development technology down to equipment used in fill-finish operations. This position entailed coordinating industry professionals, application specialist and our network of technical and logistic support teams to offer solutions that help expedite groundbreaking research through pipelines delivering life-changing treatments to patients across the globe.

At Agenus I worked to deliver cutting edge individualized immuno-oncology treatments to patients with glioblastoma multiforme. My role with the manufacturing team in the immuno-oncology division was to manufacture personalized vaccinations using tumor tissue harvested from patients within our network of hospitals and cancer centers. This position required all of the tissue processing and final fill for patient vials to be performed inside of BSCs located inside of a cleanroom environment. The tumor tissue was first processed to purify proteins using four stages of chromatography columns. Once the proteins had been purified and concentrated they were analyzed via Bradford assay and diluted to the desired final formulation dose concentration. Once properly diluted the final products were filtered and filled into vials that are labeled and sent back to the patients at their respective healthcare facilities. The entire process must be perform with meticulous care from tissue procurement and preparing of labels all the way to processing and final fill operations to ensure the patients are provided the highest quality product possible. Additionally our manufacturing team was responsible for maintaining the cleanroom in proper order, autoclaving the goods necessary for processing, and preparing buffers for chromatography and the final filling of vials.

At BioVolutions our cell culture and bioprocess team worked to develop an integrated continuous platform for the production of therapeutic antibodies. On the upstream side, I was responsible for sterilizing, assembling, maintaining and controlling the bioreactor as well as culturing the genetically modified CHO cell lines from cryogenically preserving them to expanding them through our seed train and inoculating the bioreactor. Experiments were performed on a three liter pilot scale reactor connected to an ATF2 hollow fiber perfusion system. I worked closely with our other purification technician to link primary chromatography steps directly downstream of the production bioreactor. While inventing our production platform our objective was the link upstream perfusion bioreactor technology directly and in sync with downstream automated chromatography to develop a continuous and financially viable production option for CMO's producing biosimilar antibodies. We used a pilot scale GE AKTA system to pinpoint our flowrates, cycles and buffer formulations. Eventually we had devised a complete regiment of cycles to be run that could be synchronized with our perfusion harvest rate to create a platform which balanced cell culture health and density with high antibody titer and consistent quality along with chromatography steps yielding high antibody purity and density in the final eluted product. This project required years of research, in depth problem solving and creativity to solve. Additionally refining our platform required media optimization and preparation as well as SDS-PAGE and ELISA analysis of culture harvest. Along with being a primary engineer on our bioprocess operation I was tasked with presenting our findings at bioprocessing conferences and was in charge of the development and writing of SOPs and batch records to eventually transition the company to cGMP compliance for providing first in man material for phase 1 clinical trials.

I assisted in the research of uranium and arsenic bioremediation via geobacter populations on the Colorado River. This was my first professional work with purification of genetic material which involved the extraction and purification of DNA from environmental samples and E. coli. During my time there we worked studying microbes that could be manipulated to reduce the concentrations of heavy and radioactive metals in Colorado River. We would receive soil samples from our site on the Colorado River and use bead-beater techniques to extract the DNA from the organisms present in the samples and then use PCR to amplify the genetic material we were interested in for our study. This material would then be transfected into E. coli cells for further study. Additionally in that lab we used FISH, PCR and electrophoresis procedures to identify and quantify the organisms and prevalence of our genes in the sample populations. Additionally I was making aerobic and anaerobic media, culturing and harvesting of E.coli cells, working under a laminar flow hood, diluting primers as well as preparing, running and staining electrophoresis agarose gels. I was also responsible for revising and writing operating procedures to optimize experimental results. Much of the lab work required the use of pipetting and micropipetting.

I was trained in media/harvest hold, bulk purification, preparation of bulk sampling and worked mainly with operation and monitoring of large-scale bioreactors in a clean room environment. My position was on the upstream bioprocessing team, but this also involved primary depth filtration of bulk product and eventual purification via large scale chromatography skid of pooled harvest containing novel proteins to be used for genetic therapies. The harvest material would be purified and aseptically stored in sterile bioprocessing bags inside of warehouse cold storage rooms to be further purified by the downstream purification team. I was responsible for follow GMP guidelines, using laminar flow hoods and sterile technique and was trained on centrifuge maintenance while in this position. I completed a multitude of training modules and all on-floor processes involved careful use of detailed SOPs. Working at a state of the art manufacturing facility gained me invaluable insight into the final phase of therapeutic production for a global market.