Built the flow cytometry core across 2 locations and trained personnel on the latest instrumentation and methods. Managed the flow cytometry facilities, purchased contracts, and upgraded instrumentation. Created preclinical and clinical multiparameter flow cytometry panels for multiple therapeutic agents. Developed several preclinical mechanistic and functional assays across various indications, resulting in INDs, collaborations, and progression into clinical studies. Solved immunological related issues, resulting in resolution of CRO generated errors, cost-saving measures, and positive redirection of priorities within programs. Analyzed, interpreted, and presented human and animal flow cytometry data in company meetings and organized summarized results for conferences, journal articles, and regulatory documents.

Developed methods and strategies to evaluate the effects of cancer drug therapy candidates on immune cells.

Thesis project evaluating alkylamides extracted from Echinacea purpurea and their effect on mast cells. In a mast cell model, determined that Echinacea alkylamides could inhibit enzyme, cytokine, and eicosanoid release in vitro. Echinacea alkylamides also disrupted calcium signaling in mast cells. Determined the structure of alkylamides responsible for the inhibitory activity on mast cells.Key Accomplishments:• Identified anti-inflammatory compounds that inhibit mediator release from in vitro stimulated basophils and mast cells during drug screening efforts.• Determined the relationship between structural components and anti-inflammatory activity of drug compounds during in vitro basophil and mast cell stimulation.• Discovered the structural components of drug compounds that suppress calcium signaling and inhibit enzyme release, de novo cytokine and eicosanoid production in stimulated basophils and mast cells resulting in inhibition levels up to 90%. • Presented the results of drug screening experimental research to the members of the Comparative Medicine Institute at North Carolina State University during research symposiums.• Organized weekly presentations and in-depth discussions for the immunology department faculty on advanced topics in immunology, including macrophage polarization and inflammation, infectious diseases and vaccine generation, the effects of aging on the immune system, regulation of innate and cellular immunity, micro-RNA regulation of immune cells, lymphocyte development and regulation, myeloid-derived suppressor cell function and development, and innate lymphoid cell development and function.

Provided laboratory compliance services, including risk assessments, instrumentation qualification, method development, and validation activities. Developed, executed, and reviewed cGMP method validation protocols, IOPQ protocols, and data summary reports for QA/QC departments that were reportable to the FDA. Advised pharmaceutical and biotechnology companies in quality and compliance (GXP) to provide strategies to improve compliance within the company and manage the impact of FDA violations from FDA audits. Key Accomplishments:• Improved the status of biotech/pharmaceutical companies with the FDA by enhancing employee awareness and knowledge of FDA cGMP regulations during instruction of instrument qualification, method validation, and method transfer activities.• Ensured accurate data collection and reporting was accomplished by serving as the final reviewer and approver of multiple experimental protocols executed by BSL-2 QC scientists. • Guaranteed companies complied with FDA cGMP regulations by designing, approving, and finalizing validation summary reports deliverable to the FDA.• Advised and collaborated with QA departments to establish acceptable parameters for qualification and validation activities.

Managed, prioritized and completed projects for preclinical, clinical, stability, and product release samples requested for analytical testing by internal customers within the BioAnalytics Department. Performed method development and validation, instrument qualification and troubleshooting, and method transfer activities for product lines and instrumentation. Executed cGCP and cGMP studies according to ICH guidelines and FDA rules and regulations. Performed routine lab tasks, safety audits, sample stability monitoring, and annual cGMP training.Key Accomplishments:• Managed projects for clinical, stability, product lot release samples by effectively executing experiments and evaluating data packets while meeting deadlines in a timely manner for IND applications and BLA submissions. • Met deliverables while preceding deadlines during the management of the human antibody clinical project. Designed a rapid and accurate automated method for analyzing human antibody levels and led clinical activities quantifying IgG antibody and IgG subclasses in human plasma.• Completed project developing and validating method to quantitate an unknown impurity in the lots of a product line and analyzed the risk assessment of the concentration of impurity in product lots, preventing the loss of company money by saving the product lots from disposal.• Established purity and stability requirements of preclinical, clinical, stability, and product release samples for the treatment of chronic obstructive pulmonary disease, hemophilia, and severe combined immunodeficiency. • Designed method development and validation, method transfer, and instrument qualification protocols for product lines and new instrumentation, according to FDA rules and regulations and ICH guidelines, to establish precise and reliable specification criteria for protocols.

As a team leader, supervised and developed employees responsible for executing pipeline activities for Arabidopsis thaliana, corn, and soybean plants. Managed facility weekend projects and met deliverables for all pipeline activities. Determined potential hits for use in the field by assessing the effectiveness of target genes inserted into transgenic plants that improve plant yield and health. Key Accomplishments:• Weekend group leader responsible for generating, assigning tasks, and managing employees executing pipeline tasks for A. thaliana, corn, and soybean plants.• Managed, trained and developed employees on pipeline tasks and activities.• Managed the facility by programing environmental growth champers containing experimental plants, monitoring the health of experimental plants, and scheduling pipeline activities to guarantee the execution of greater than 100 tasks for accurate data collection. • Evaluated the effect of target genes on plant health and seed yield during stressed growth conditions leading to the generation of hits for implementation into various crops.• Performed automated molecular cloning of targeted genes of A. thaliana genomic DNA using a Tecan robotic system.

Assisted scientists with the development and optimization of experiments within the Formulations and Drug Discovery Group. Performed influenza and Bacillus anthracis immunogenicity studies. Completed PK/PD diabetic drug trials. Executed ELISAs for various antigens and antibodies. Assisted with the maintenance of laboratory equipment and troubleshooting of software. Performed assays in accordance with GLP guidelines. Key Accomplishments:• Collaborated with scientist during vaccine development and established effective vaccine formulations and route of administration for use in influenza and B. anthracis immunogenicity animal studies. • Established serum antibody titers from mice and rats for immunogenicity studies. • Performed cell culture techniques and plaque assays for flu and measles viruses and assessed cell viability using flow cytometry.• Trained by formulation scientists on the drug development process and determined the effectiveness of drug formulations and medical devices in preclinical trials.• Supported preclinical trial studies assessing the efficacy of medical devices, drug and vaccine formulations, resulting in improvements in drug delivery, drug adsorption, and antibody titer levels. • Evaluated the purity of drug and vaccine formulations by performing HPLC assays, PAGE, and western blot analysis in support of preclinical trials for recombinant PA, Flu, Exendin-4, and GLP-1. • Animal Models and Trials:o Glucose monitoring/insulin production - Zucker Diabetic Fatty ratso Exendin-4 and GLP-1 PK/PD diabetic drug study - Yucatan mini-swine and Yorkshire pigso B. anthracis and influenza immunogenicity study - BALB/c Miceo Influenza topical creams (Vehicle) immunogenicity study - Brown Norway Rats

Assisted scientists in developing and optimizing experimental protocols within the Laboratory of Pulmonary Pathobiology. Performed assays such as PCR, western blot, ELISA, bacterial transformation, and cell culture. Completed clinical studies to assess the levels of various allergens in homes and daycares. Updated the laboratory journal article library and presented journal articles to senior staff during weekly meetings.Key Accomplishments:• Assisted scientists in developing and optimizing experimental protocols within the Laboratory of Pulmonary Pathobiology in the areas of PCRs, western blots, ELISAs, bacterial transformation, and cell culture assays. • Developed, evaluated, and executed clinical immunology trial study protocols, electronic databases, questionnaires, and forms.• Obtained data for questionnaires and forms from Spanish speaking participants of the clinical immunology trial studies by effectively communicating in Spanish and improving the data collection process. • Presented experimental data during weekly laboratory meetings and annual poster sessions.• Trained two Summers of Discovery participants and a Technical IRTA fellow on various aspects of the methods, procedures, and equipment used in the experiments, including clinical sample processing, ELISA, and data interpretation.• Published research: • Abatement of cockroach allergen (Bla g 1) in low-income, urban housing: A randomized controlled trial. J Allergy Clin Immunol. 2003 Aug;112(2):339-45. • Exposure to indoor allergens in day-care facilities: Results from 2 North Carolina counties. J Allergy Clin Immunol. 2005 July:116(1):133-39.