Juan Cabrera-Luque
Senior Manager, Analytical Development (Immunology) @Novavax
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WORK HISTORY
Senior Manager, Analytical Development (Immunology) @Novavax
Gaithersburg, MD, US
Lead and build a team of professionals towards developing, qualifying, and validating immunoassay methods for characterization of recombinant protein vaccine products.· Define strategic goals for the Immunology group.· Participate in cross-functional workflows and provide scientific guidance to teams.· Apply new cutting-edge technologies to improve throughput for in-process testing and enhance capability of product characterization.· Perform method transfers to QC and other groups and external partners.· Thoroughly analyze results and methods, solve analytical problems, troubleshoot assays and meet regulatory expectations for analytics.· Prepare and review standard operating procedures, method development reports, qualification/validation protocols and reports, and scientific journal publications and presentations.· Write, edit, and review analytical sections of CMC regulatory filings.· Maintain effective communication with process development, formulation development, QC, QA, research, and clinical immunology.· Present scientific findings at internal and external meetings.· Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.· Provides input into process and policy improvements, administers budgets, timelines and performance requirements.· Assigns work and provides guidance to subordinates to achieve goals in accordance with established policies.
EDUCATION
University of Valencia
Doctor of Philosophy (Ph.D.), Biochemistry and Molecular Biology
Universidad de Córdoba
BS, Biochemistry and Molecular Biology
Universidad de Córdoba
Master's degree, Biochemistry and Molecular Biology
SKILLS
ABOUT JUAN CABRERA-LUQUE
Highly versatile and creative scientist offering more than 22 years of experience in the field of Biochemistry and Molecular Biology and more than 10 years in project management. Research experience includes experimental design, project development, cross-organizational collaboration, SOP development, optimization and writing, tech transfer validation packages, team leadership and supervisory roles. Viewed as crucial go-to resource in offering scientific as well as problem solving support and consultation to peers. Participation in pre-clinical projects working on the development of novel enzyme-based therapeutic, diagnostic and managerial approaches to Inborn Errors of Metabolism with a particular focus on Phenylketonuria (PKU), Urea Cycle Diseases (UCD) and Maple Syrup Urine Disease (MSUD) among others. Extensive experience on IVD test and LDT assay development using innovative technologies such as digital droplet PCR and genome mapping systems (BioNano). Sound knowledge of NGS platforms such as Illumina sequencing platforms, digital MLPA, PacBio, and acquired a wealth of experience in microarray technologies (CytoScan HD, XON and Axiom).CORE STRENGHSLeadership; Project development from data-derived hypotheses; Grant writing (philanthropic and federal institutions); Complex scientific concepts articulation; Interdisciplinary collaboration; Scientific reports, SOP and guideline writing and review; Budgeting and funds management; Project management under tight schedules; Public speaking and presentation delivery (posters and weekly updates); Sound experimental design; Assay development and optimization.SIGNIFICANT CONTRIBUTIONSCo-led the establishment of COVID-19 testing at GeneDx from the ground up; Develop liquid handling protocols using Opentrons OT-2 robots for high-throughput screening of COVID-19 samples; Optimized and coordinated the implementation of ThermoFisher Microarray technology (CytoScan HD) in the production lab; Improved CNV detection using real time PCR and transfer assay to production lab which increased the sensitivity and reduced the cost of the assay.
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