Kyle Arend, Phd Email & Phone Number

Chapel Hill, Nc, Us

Rtp, Nc

Senior Scientist, Analytical Sciences• Support process development, design, scale-up, technology transfer, and start-up of cGMP manufacturing operations.• Project lead for developing, qualifying, and validating analytical methods used for in-process testing, extended product characterization, and batch release testing for virus-like particle product.• Establish potency assay reference standard qualification and stability monitoring programs• Project lead for technical writing for comparability of a commercial tech transfer and scale-up for a mammalian cell culture process that produces a monoclonal antibody.• Project lead for development of ligand-binding potency assay for advanced biologic to treat respiratory disease• Assess gaps in CMC and Clinical testing and technical writing for IND/BLA regulatory filings.• Manage team priorities and oversee budget/planning for technical writing, research, and validation projects in cGMP environments.• Manage cross-functional teams of engineers and scientists.• Lead and support quality audit campaigns of testing laboratories and pharmaceutical suppliers.

Rtp, Nc

Process Scientist, Analytical Sciences• Contributes to the validation lifecycle of facilities, utilities, processes, analytical methods, and equipment following GAMP5® principles.• Characterizes, develops, and validates analytical methods used for in-process testing, product characterization, and batch release testing.• Drafts method qualifications and validations for a broad range of analytical equipment including microplate readers, flow cytometers, spectrophotometers, hematology analyzers, digital osmometer, cell counters, and water purification systems. • Executes IQ/OQ/PQ protocols, investigates and resolves protocol deviations and drafts final summary reports.• Assesses process capability using statistical tools and a thorough review of production batch data.• Leads and supports quality audit campaigns of testing laboratories and pharmaceutical suppliers.• Supports process development, design, scale-up, technology transfer, and start-up of CGMP manufacturing.• Utilizes microbiology subject matter expertise to implement new but proven technologies to improve efficiencies, communication, quality, costs, and performance.• Designs and implements environmental monitoring programs for cGMP facilities and cleanrooms.• Leverages industry expectations and regulatory guidances (ICH, FDA, USP) to provide best-in-practice solutions and documentation.

Chapel Hill, Nc

Microbiology and Immunology Department - Laboratory of Dr. Nathaniel MoormanAs a graduate student my research efforts were focused on the lytic replication cycle of the beta-herpesvirus, human cytomegalovirus (HCMV). I strove to better understand how HCMV is able to commandeer cellular machinery, re-program cell signaling networks, and re-direct resources to facilitate the production of new virions. In particular, my dissertation research identified novel mRNAs transcribed from the viral genome that were important for lytic replication, as well as, demonstrated that the 5' untranslated region of major immediate early mRNAs is a critical regulator of translation efficiency. Through these research endeavors the lab sought to identify new targets for the development of antiviral drugs and develop a better understanding of the basic cellular processes of transcription and translation by utilizing HCMV as a tool.Graduate Awards:National Science Foundation - Graduate Research FellowshipNational Institutes of Health - T32 Virology Training Grant

Madison, Wisconsin

Plant Pathology Department - Laboratory of Dr. Andrew BentAs a student researcher my efforts were focused on identifying genes involved in plant innate immune responses, particularly against bacterial pathogens. My project involved screening a large library of single gene knockout mutants of the model organism Arabidopsis thaliana for changes in susceptibility to microbe-associated molecular patterns (MAMPs). In addition, I helped measure plant growth, yield, and disease resistance of genetically modified soybean crops in the lab field study. Furthermore, I also assisted the lab through numerous other duties including ordering supplies, preparing reagents, and maintaining lab equipment.Undergraduate Awards:Distinctive Scholastic Achievement AwardCollege of Agricultural and Life Science - Academic ScholarshipWisconsin Academic Excellence Award

Bangkok Metropolitan Area, Thailand

Faculty of Science - Phayathai Campus - Laboratory of Dr. Padungsri DubbsOne of the main focuses of the lab is understanding mechanisms of antimicrobial resistance. During this research experience I procured hands-on experience with molecular biology techniques including PCR, Western blotting, immunoprecipitation, molecular cloning, DNA isolation, and agarose gel electrophoresis. My main project was to analyze clinical isolates of antibiotic resistant strains of Acinetobacter baumannii for amino acid mutations in bacterial enzymes proposed to confer antibiotic resistance.

Doctor Of Philosophy - Phd, Microbiology And Immunology

Activities and Societies: UNC - Science and Business Club, NC DNA Day Ambassador, BBSP Peer Mentor, Graduate Teaching Assistant, UNC.

Bachelor Of Science - Bs, Genetics

Activities and Societies: UW - Peer Learning Association, Club Volleyball Team, Recreational Tennis League, Genetics and Biology Tutor