Melody Lapinskas Email and Phone Number

Establish project management process and standards. Manage development projects, GMP campaigns, and operations/process improvement projects. Ensure completion of deliverables are achieved on time with customer satisfaction. • Effectively facilitate project meetings with internal and external stakeholders• Create project timelines, Gantt charts, and document trackers• Responsible for management of project kick offs, updates meetings, and client site visits• Successfully liaise clients and internal stakeholders, develop and manage client relations• Lead internal system / technology optimization projects from discovery to implementation and vendor management

Managed/conducted development, execution, and analysis of tissue-based assays in support of programs across the portfolio in all phases of drug development from discovery to clinical trials. • Reviewed consumables expenditure and facilitated purchasing agreements with vendors • Coordinated and evaluated new vendors/platforms/software, generated budget proposals for cost analysis • Collaborated, assisted, and updated project teams with goal alignment and completion • Organized and facilitated LIMS workflow/process development and improvement meetings• Established, streamlined, and integrated workflows and processes for new systems and platforms

Grew the pathobiology lab within translational science; established new processes, implemented new systems and platforms for resource management, standardized protocols, simplified work streams, supported both clinical and non-clinical programs. • Communicated experimental plans, objectives, and timelines to cross-functional groups, project teams, and stakeholders • Facilitated integration and provided development guidance for new internal and external systems and software

Managed/executed histology studies from necropsy to IHC staining and imaging as contracted histology associate to FTE within the histology group of Exploratory Toxicology.• QA/QC of study protocols, data, reports, amendments and deviations to ensure the quality and compliance of GLP and non GLP templates and requirements • Led pre-necropsy/study meetings in support of programs across the portfolio including but not limited to first in human and GLP studies, address agenda items, document decisions, and follow-up when necessary • Created, maintained, and updated site specific and company wide databases • Developed detailed SOPs for new processes and documents

• Used multilocus sequence typing (MLST) to detect Leptospira infection in clinical patients• Sorted and homogenized various animal tissues with Trizol Reagent.• Extracted DNA, RNA, and protein from homogenized samples and bacterial cell cultures.• Analyze DNA with gel electrophoresis, quantitative real time PCR, and PCR.• Performed small animal surgeries and maintained animal husbandry.• Subcultured and maintained various Leptospira strains.• Conducted various experiments to test for immunity in small rodents against Leptospirosis. • Sequenced Leptospira genome for Leptospira Genomics and Human Health collaboration project.