Julie Wilkinson

About Julie Wilkinson

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.

Experience

1. President

   Life Science Consulting, Inc

   Nov 2015 — Present · Washington, DC, US

   I specialize in consulting for IVD product development, driving strategic initiatives that enhance organizational effectiveness. • Engaged with clients including CROs, academic research centers, and government agencies like the NIH, BARDA, CDC and DARPA. • Optimized processes for both early- and late-stage product development, ensuring alignment with industry standards. • Developed skills in strategic planning, FDA regulatory compliance, and cross-functional collaboration within the life sciences field.

Education

• The Ohio State University

  M.S., Molecular Genetics, Biology

• The Ohio State University

  B.S., Biology, Genetics

Skills

• Validation
• Drug Discovery
• Vaccines
• U.s. Food and Drug Administration (Fda)
• Immunology
• Assay Development
• Cancer
• Biopharmaceuticals
• Life Sciences
• R&D
• Cell
• Biotechnology
• Research and Development (R&D)
• Product Development
• Hardware Diagnostics
• Fda
• Good Laboratory Practice (Glp)
• Immunoassays
• Cell Biology
• Glp
• Medical Devices
• Clinical Research
• Flow Cytometry
• Lifesciences