ExpertiseQuality Control | Product Release and Stability Testing | CAPA | GMP | Molecular Biology qPCR Virology | Troubleshooting Investigation | ELISA | Cell Culture-Cell Banking | Assay QualificationProtein Analytics | SOP | GLP | Lab Management | Vaccines | Potency Bioassay DevelopmentProfessional Summary- An experienced Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) regulated laboratory manager, with demonstrated ability to convert a development-level laboratory into a GLP regulations compliant laboratory. - A detail-oriented analyst with technical expertise in GMP and GLP phase-appropriate regulated product release and stability testing. - A versatile and engaged bench scientist with a depth of experience across many processes and product development areas including: experimental design (DOE), cell line development, cloning, tissue culture, cell banking, protein analytics, carbohydrate analysis, formulation, ELISA potency bioassay, qualification, and transfer. Experienced in working within Biological Safety Level -2+ (BSL II+) designated areas.- A highly motivated and collaborative associate, able to prioritize work on multiple projects and to meet deadlines in a fast-paced environment. - A trusted writer, data verifier, reviewer and editor of Method Development Reports, Test Methods, Qualification Reports, Standard Operating Procedures, and Training Plans.Recent Accomplishments: Successfully established and maintained GLP compliance in the Bioassay and Biological Characterization development laboratory. Specialties: Computerized Maintenance Management Software (MAXIMO), GMP and GLP management of analytical and controlled environmental equipment, strong writing and editing skills, enjoys cell culture, ELISA, qPCR and cross-team collaborations.