The Charles C. Gates Biomanufacturing Facility (GBF) is a mission-based Good Manufacturing Practices (cGMP) facility. Our mission is to accelerate the translation of scientific discoveries into human clinical trials as safely, efficiently, and cost effectively as possible according to high quality standards.At the GBF, we collaborate with basic science and clinical investigators to successfully translate laboratory discoveries into early phase clinical trials. We leverage our strengths in analytical development and quality control to deliver cell-based therapies and protein biologic drugs for use in pre-clinical investigations and Phase I and Phase II human clinical trials.Personally, I am focused on the application of Flow Cytometry techniques and cell-based assays for Quality Control of cell therapy products, including Chimeric Antigen Receptor T Cell products (CAR-T) . Flow Cytometry methods are well-suited to the characterization of distinct cell populations with respect to Immunophenotype and trans-gene expression.The challenge for Quality Control analysts is to streamline and standardize client methods developed in concert with the product itself, and to make results generally more accurate and reproducible. For platform methods, labs can enable off-the-shelf Flow Cytometry assays for quick determination of cell populations and measurements of cell viability, among other parameters. Such pre-qualified Flow Cytometry assays are useful to assess incoming patient material, prior to processing, and may also be used for process monitoring.

Biological method development, routine microbiological testing, and day-to-day operations support for this environmental testing laboratory• Led laboratory operations to ensure timely sample processing and accurate delivery of client results, within specified turnaround-times• Led biological method development efforts including molecular analysis, microscopy and classical growth-based assays• Developed quality management program to better track laboratory inputs and outputs in real time and establish record of compliance with regulatory agencies• Assisted in client-requested research projects and/or consultation related to quality control• Generated intellectual property relating to novel methods and processes for analyzing plant material, extracts, and infused-products

Designed and executed client-funded and internal strategic investigations into the complex testing requirements of human cellular and tissue-based therapeutics (HCT/Ps) and biologic drug products. Investigations focused on implementation of molecular methods to characterize and provide quality control metrics for HCT/Ps, and to enable rapid pathogen detection as an alternative to traditional microbiology sterility testing. Lead large research studies from design and development to method validation and operational implementation. Major contributions include:• Implemented Real-Time PCR based Mycoplasma testing in a wide variety of sample matrices, including cell culture based products, and related culture media and sera• Developed proprietary Real-Time PCR based screening method designed to detect bacterial and fungal pathogens in human tissue recovery swabs with a high degree of sensitivity and specificity in less than 24 hours• Assisted in culture and characterization of human mesenchymal stem cell (MSC) populations with the end goal of developing functional assays for identity, purity, and potency

• Used proprietary high-pressure methods to solubilize and refold human proteins for pharmaceutical applications, specifically to reduce protein mis-folding and protein aggregation• Designed and executed experiments to optimize refolding conditions for different model proteins, using a variety of analytical methods to assess refolding yields including SDS-PAGE and HPLC• Collaborated with pharmaceutical companies and CMOs to improve their production processes for protein therapeutics; specifically to increase yield, reduce materials costs and time in plant

Research and Development: • Conducted high-throughput RNAi screening, for candidate gene discovery. Was instrumental in executing screening projects for clients, from planning phases to confirmation studies• Delivered microRNA profiling services for clients, and generated final project summaries for profiling results• Conducted product testing and product research with a focus on quality improvement• Expanded use of qPCR for gene expression analysis, and developed methodology for offering qPCR confirmation to screening data

Research and Development:• Collaborated on internal and external RNAi screening projects, gaining experience with a variety of automated laboratory equipment and cell-based assays• Performed in vitro experiments using siRNA transfection and lentiviral transduction strategies to modulate gene expression in cell culture systems• Responsible for method development on automated platforms and troubleshooting to resolve technical difficultiesRNA Production: • Responsible for custom synthesis, QC analysis, purification, pooling and plating of RNA/DNA samples for client orders. Employed a wide range of scales and modification patterns• Developed expertise in various robotic liquid handling systems and automated tube/rack management systems, writing new methods and SOPs for high-throughput production• Managed creation and maintenance of genome library sets, with a focus on quality control and process improvement• Responsible for maintenance of chemical synthesizers, testing of newly developed supports and chemical modifications for use in chemical synthesis

• Studied human genetic variation relevant in lung disease models, with a detailed analysis of newly discovered human gene polymorphism important in the pathophysiology of Acute Lung Injury• Investigated the genetics of human cognition, by comparing genome-wide insertions and deletions among primate genomes using a variety of hybridization techniques• Used microarray technology to study the effects of VEGFR-2 inhibitors and Alpha-1-Antitrypsin in rat lungs to model human Emphysema• Performed genome-wide investigation into LINE-1 retrotransposons in the mouse genome, to build a database of recent LINE-1 insertion events, and to clone and characterize target sites

• Designed and executed experiments to test surgical spinal implants in the lab, using human cadaver spines and a custom built 3D camera system to measure spinal motion• Responsible for supervision of student employees and daily laboratory operations• Responsible for the collection and analysis of data related to investigations into spinal biomechanics, using a variety of spinal instrumentation systems• Harvested, radiographed and prepared cadaveric spinal specimen for study• Collaborated in manuscript writing and seeking external funding for projects

• Separated and analyzed DNA, RNA and proteins to help develop an inhaled antimicrobial treatment for Cystic Fibrosis (using a mouse model)• Performed various gel electrophoresis techniques including Western, Southern, and Northern blotting• Performed RT-PCR and various cloning experiments• Anesthetized laboratory animals and harvested organs for study• Supported laboratory operations through preparation of reagents, buffers, solvents, etc.