o Led and created a new business unit, Realm Pharma Services by integrating two sister companies (Invicro and Ambry Genetics) across three different sites with $16MM in year one and over $100MM in year 5 revenue target forecast. o Created, built, and managed Realm Pharma Services Project Management Organizationo Integrated, lead, and managed three lab sites across the US consisting of Clinical and Research Pathology and Genomics CRO services in a CAP/CLIA regulated environment.o Led the development and execution for product development strategy and developed the pharma services roadmap.o Business Unit leader responsible for driving financial metrics, product portfolio, partnerships and collaborations with pharma partners, and lab regulatory compliance and certifications.o Creation and management of Realm Pharma Services portfolio for monthly revenue forecast and recognition at >$2MM per month target revenueo Operations Department Head responsible for Pathology and Genomics lab operations, PMO, and data managemento Established process improvements to efficiently execute on portfolio backlog of >$5MM to increase revenue recognition and decrease operational expense.o Oversaw Genomics R&D assay and pipeline development, and execution of validated genomics and pathology assays in a CAP/CLIA regulated environment.o Support BD in client facing opportunities for Pharma scoping and contract awards

o R&D department head managing three functional areas, Assay Development, Automation, and Advanced Genomics Services (Pharma services division)o Led, created, and implemented Ambry corporate portfolio and processo Develop and drive the R&D and Pharma Services strategy, portfolio, and pipeline.o Member of Ambry Leadership team to ensure alignment on corporate strategies and goals, successful execution of R&D department aligned with corporate goals, employee engagement, and maintain operations within Annual Operating Plan.o Project champion and sponsor supporting product development within the PDP process with creation of Core Team Processo New product development and delivery of regulated assays (CAP/CLIA) to the clinical labo Maintain, support, and update current clinical product offering.o Develop, validate, and execute, custom products to support pharmaceutical clientso Evaluate new chemistries, technologies, and platforms to ensure cutting edge innovation in R&D and Pharma Services

o Lead, manage, and drive cross functional core teams on activities to achieve program deliverables for each phase in the product development life cycleo Develop, drive, and implement strategies for IVD Non Invasive Prenatal Testing programs within Clinical Genomics product developmento Manage project coordinators to support daily program operations (deliverable tracking, meeting management, and document management)o Led the successful launch of three regulated products within two yearso Manage project budgets (>$10 million), forecasts, resources and timelineso Manage external partners and clinical site collaborations

- Drive and coordinate the operations of internal core teams, diagnostics partners, and external global CROs to ensure the global execution of the Companion Diagnostic assay to support the Keytruda (anti-PD-1) program- Established and determined MBD global outsourcing strategy through vendor selection, evaluation, qualification and oversight- Developed and implemented department process improvement to support in house and outsourced clinical biomarker assay development- Chaired weekly assay review committee (ARC) meetings to evaluate clinical biomarker assay feasibility and determine resource allocation- Developed and implemented department strategy by driving Senior Leadership team to achieve goals and objectives

Managed Non Human Primate (NHP) projects at external CROs and rodent Genetically Engineered Models (GEM) projects internally in order to meet department deliverables within a yearly budget of $10 million

Managed the strategic planning of profiling projects and budgets that support a portfolio of over 80 projects a year in the therapeutic franchise areas of Bone, Respiratory, Immunology, and Neurology that operated at a $5.5 million allocated budget

Managed the strategic planning of profiling projects and budgets that support a portfolio of over 80 projects a year in the therapeutic franchise areas of Bone, Respiratory, Immunology, and Neurology that operated at a $5.5 million allocated budget

- Collaborated and performed as a Co-PI in developing and implementing clinical trial protocols for safety and efficacy- Coordinated activities including study initiation, IRB submission, protocol and regulatory document reviews, budget development and management, subject recruitment, study procedures, monitored timelines, data collection and analysis

- Directed and ensured that all manufacturing processes complied with cGMP and FDA regulations through audits- Managed 11 employees to ensure product quality and employee compliance

- Established and revised quality systems, SOP’s, and regulatory procedures- Ensured all departments were in compliance with FDA and other government regulations through internal audits and monitoring

Coordinated activities including study initiation, development and utilization of a real-time PCR assay (MethyLight) to discover DNA methylation markers that can be used for early detection and proper diagnosis of lung cancer