Gary Hyde

Background

About Gary Hyde

PROFESSIONAL PROFILE : Gary is a seasoned manufacturing process engineer and consultant with deep knowledge, expertise and success in driving transformational process improvements, finding solutions for seemingly intractable problems, and building strong, capable cross-functional teams. Gary is deeply committed to US medicinal product manufacturing excellence, which can only be achieved by employing phase appropriate risk-based and evidence-based decision making, underpinned by Lean principles at all levels. Gary integrates his subject matter expertise with that of his clients, using a systematic, process focused, stakeholder-oriented approach that keeps teams focused, on-track, and moving forward to stellar result. He has delivered transformative results across all product lifecycle stages including process design during pre-clinical development, process design and qualification during clinical development, and continued process verification following commercial approval. Expertise Medicinal Product Quality, Compliance and Transfer Quantifying Existing Processes Cause Problem Solving Lean/Six Sigma Improvement Quality Risk Identification and Decision Making Stakeholder Engagement/Team Leadership w/ Client Documentation Ways of Working Visualizing, quantifying and assessing current process performance using controlled documentation, records and process participant interviews Capturing process SME knowledge across functional areas to enhance the effectiveness of process improvement Characterizing processes using engineering statistics and graphical analysis to extract maximum benefit from existing data and crafting additional data collection as needed. Identifying and collaboratively implementing phase-appropriate quality risk management practices aligned with the client’s risk tolerance. Creating a precise, quantitative problem definition as a basis for identifying potential cause(s) and quantitative determination of their mitigation. gary.hyde@propharmagroup.com, 925-967-8435