Julie Wilkinson Email and Phone Number
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Bringing business to your science! Transforming great ideas into profitable products on the market improving the lives of generations to come is truly Science Serving Humanity and it is what I do best. I’m a big picture strategist and analytical problem solver with an enthusiastic and positive approach to life. My experiences of progressive scientific, management, entrepreneurial, and executive leadership in the life science industry has given me a diverse skill set including:- technology assessment- due diligence- strategic planning-FDA product development-new technology integrations-technical design, and -business operations. - Developed diagnostic platforms, applications and reagents for IVD class II medical devices that generate annual sales of $500 million. - Led product development activities that saved $5.4 million in R&D costs in one year.- Established and directed GCLP, GMP, and CLIA testing labs- Provided scientific and project leadership to migrate a CLIA microarray test platform resulting in a 30% increase in test products with enhanced precision.- Led 510K product development activities for a new HIV diagnostic instrument system.- Managed projects from concept through development, manufacturing transfer, regulatory submission and commercialization.- P&L responsibility of over $10 million.- Led a dual ISO-9001/13485 certification process for an international technology provider. - 3 U.S. Patents for analytical technologies- 10 peer-reviewed publications and book chapter- 40+ technical white papers.- 13 invited speaking engagements.- 29 scientific conference presentationsSpecialties: Consulting, IVD, Companion Diagnostics, Complementary Diagnostics, FDA 820.30 Design Control, R&D Strategy, Scientific Approach, Organizational Transformation, Analytical Thinking, Problem Solving, Product Development, Biomarker Development, Program Management, In-licensing evaluation, Method and Process Validation, Clinical Research, Immunology, Oncology, Hematology, Infectious Disease, Lab Automation, Systems Biology, FDA 510(k), QMS, QSR, GMP, GLP, ISO, Global and Cross-functional Teams, Communications.
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Executive ConsultantSherpani, Llc Jun 2022 - Present
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Executive Consultant In DiagnosticsLife Science Consulting, Inc. Nov 2015 - PresentWeston, Fl, UsProviding hands-on consulting in defining strategies, refining processes, and optimizing organizations for early- and late-stage IVD Product Development of Class I, II, and III diagnostic medical devices. -
Senior Director Ivd Product DevelopmentPersonal Genome Diagnostics Jul 2019 - Mar 2020Salinas, California, UsLed IVD product development of cutting-edge next gen sequencing (NGS) Class I-II in vitro diagnostic technologies focused on tissue and cell-free DNA genetic profiling in cancer. -
Director Of Product DevelopmentAbbott Jan 2017 - Nov 2018Abbott Park, Illinois, UsHands-on consulting role building and leading engineering, scientific and cross-functional teams to complete product development activities and optimize processes for complex hematology diagnostic analytical system Class II FDA and CE-IVD products . Overall responsibilities were: - Creating and executing comprehensive R&D project plans - Establishing and leading successful inter-disciplinary and cross-functional project teams to complete critical project milestones in compliance with FDA design control and global regulatory requirements.- Providing scientific expertise in analyzing critical issues, define strategies to resolve and implement solutions.- Interfacing with executive leadership on matters requiring coordination of activity across organizational units.- Providing strategic input and technical guidance to development teams and internal stakeholders.- Proactive exploring product innovation opportunities driven by technology, customer needs, and market opportunities. -
Director Of Bioanalytical Assay DevelopmentImmuno Laboratories Nov 2015 - Dec 2016Fort Lauderdale, Fl, UsAs a consultant, I contributed scientific and project leadership expertise for launching a new microarray biomarker platform CLIA Laboratory Developed Tests (LDT) for food sensitivity biomarkers which added 30% to the testing menu and increased testing precision 6-fold.Led the design, characterization, development, validation, technology transfer, documentation, and training activities of a microarray multiplex immunoassay platform for routine clinical testing.Created and executed a project plan that coordinated internal technical activities with seven cross-business service providers including biostatistics, software, hardware, informatics, IT, manufacturing, and commercialization. -
Chief Operating OfficerImmunosite Technologies, Llc Nov 2013 - Oct 2015Miramar, Florida, UsAs COO of ImmunoSite Technologies, I managed the company P&L budget and directed activities to maintain the focused and flexible GMP operations required by our service-based contract R&D and testing company. Our clients were in the pharmaceutical, life science and manufacturing industries.Implemented large-scale high throughput analytical bioprocess projects of $10 million, involving risk assessment with mitigation plans, technical direction, capital expenditure, contracts, vendor selection and qualification, third party design engineering partners, GMP facility modifications, new staff recruitment and training, team building, mentoring, and project management. Directed the implementation of QMS quality metrics to all programs and services as part of establishing a dual certification in ISO9001:2008 and ISO13485:2003. Expanded staff training and professional development, and added processes for customer technical support and customer feedback. Results were highly productive teams and high client satisfaction.Established and managed a company-wide IT and telecommunication systems and infrastructure compliant with industry best practices and safeguards for GMP operations that ensured data integrity, business continuity, and efficient disaster recovery. Result was a secure IT system that performed without interruption and zero loss of data. -
Director Reagent Product DevelopmentBlue Ocean Biomedical Jun 2012 - Nov 2013Pembroke Pines, Fl, UsCreated the strategy and directed all activities for product design characterization, development, method validation, process validation, and manufacturing transfer, of 9 system reagents and controls for a diagnostic class II analytical system. Results were FDA approval in 9 months and a worldwide launch resulting in $100 million sales the first year. -
Vp Biomarker Laboratory Services And Client RelationshipsImmunosite Technologies, Llc Jan 2010 - Dec 2012Miramar, Florida, UsEstablished and managed multi-million dollar client partnership relationships, directed laboratory operations, method and process validation, and biopharma clinical trial biomarker testing projects. I provided strategic direction on designing efficient biomarker and companion diagnostic (CDx) testing strategies for biotherapeutics using complex HTP analytical assays to clinical research investigators, clinical trial sites, and biopharma trial sponsors; and established new CLIA and GCLP testing laboratories, assays, and processes that provided accurate, precise, and reliable testing services of clinical trial samples. I brought technical, regulatory and management experience in diagnostics and clinical research to client relationships, business management, new technology integration, and testing services within a GLP organization and total Quality Management System.Reporting to the CEO in charting the strategic direction of Biomarker Lab Services while assuring its accountability to our staff and clients. Managed the global marketing efforts to improve and sustain awareness of ImmunoSite Technologies vision, mission and values. Created and implemented a comprehensive marketing and communications program, including strategies, budgets, marketing, and public relations activities. This included the design, production, and distribution of materials needed for technical publications, conference exhibits, advertising, brochures, website content, and press releases, as well as the management of staff and strategic consultants. Results were $7 million in new business the first year and sustained growth.
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Senior Staff Scientist - Director Lab OperationsBeckman Coulter Dec 2004 - Dec 2009Brea, California, Us•Designed immune-based biomarker testing strategies for use in clinical trials and defined companion diagnostic (CDx) development plans for pharmaceutical, biotech, and biopharma partners. •Established and directed clinical research testing laboratories for defining new biomarkers of transplantation tolerance.•Worked directly with clients to provide method validation, custom validated integrated solutions and biomarker platforms from a broad product portfolio of genomics, proteomics, cellomics, and automation.•Managed department activities (budgets, resources and project management).•Developed Standardized Biomarker Assays for Cell-based Functional, Immunoassays, NGS, Gene Expression, 2-D HPLC, and Microarrays (protein & nucleic acid), for biologics, drugs and vaccine clinical trials. •Developed biomarker applications for Cell Proliferation, Mixed Lymphocyte Reaction (MLR), Intracellular Cytokines (ICS), Cytotoxicity, Apoptosis, Elispot, Treg Function, Multiplex, Bead-based Capture.Disease area focus was oncology, infectious diseases, transplantation, and autoimmunity. -
Group Manager, Cytomics ApplicationsBeckman Coulter Dec 2001 - Dec 2004Brea, California, Us•Managed the Immune Monitoring Applications group activities (budgets, resources and project management)•Led engineering/scientific and cross-functional teams. •Developed the FC500 Flow Cytometer; LH750 Hematology Analyzer; Integrated Robotic Sample Prep and Biomarker Systems and reagents.•Patented Automated Intracellular Cytokine Staining Methods.
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Staff Research ScientistBeckman Coulter Dec 1997 - Dec 2001Brea, California, Us•Investigated new technologies and licensing partnerships for new products, and patented innovations in hematology and immunology. Nanoparticles; Gene Arrays; Automation; Fluorescence Amplification; FISH; Fiber Optic Array Detector; Novel Red Dyes; Cancer Biomarkers; Multiplex Immunoassays; qtPCR; Quadrupole Mass Spectrometer Detector; Raman light scattering; Surface Plasmon Resonance; .
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Product Development Scientist, Immunology R&DBeckman Coulter Jul 1993 - Dec 1997Brea, California, Us•Developed IVD flow cytometry systems, biomarker assays, reagents and controls including Unitized T-cell Stimulation Assay Kit; Monoclonal Antibody Reagents; Control Cells; Cancer Biomarkers; Class I Tetramers; Apoptosis Markers; Coulter XL Flow Cytometer; Hematology Analyzers.
Julie Wilkinson Skills
Julie Wilkinson Education Details
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The Ohio State UniversityGenetics -
The Ohio State UniversityBiology
Frequently Asked Questions about Julie Wilkinson
What company does Julie Wilkinson work for?
Julie Wilkinson works for Sherpani, Llc
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Julie Wilkinson's current role is Advisor | R&D Leader | Entrepreneur | Diagnostics | Personalized Medicine.
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What schools did Julie Wilkinson attend?
Julie Wilkinson attended The Ohio State University, The Ohio State University.
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Julie Wilkinson has skills like Immunology, Lifesciences, R&d, Biotechnology, Flow Cytometry, Medical Devices, Cell Biology, Life Sciences, Biopharmaceuticals, Immunoassays, Cancer, Validation.
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