Hands-On Technical Operations Support For Growing Biotech
Expedite clinical readiness and extend your runway with phase-appropriate processes, procedures, and controls for rapid growth and consistent quality.
Control it
Dr. Stuart Irwin is a multidisciplinary veteran of biologics development with a career spanning cell and gene therapy, engineered tissues, and molecular products. Specializing in operational readiness and reliability, he began his career as an operations management consultant for automotive assembly, installing operational excellence and lean manufacturing systems. Upon entering biologics, he discovered that traditional manufacturing tools are relevant in biologics, even though the means of production can make decisions.
Process characterization may be limited early in the game, and subject matter experts must remain involved until it is complete - in the interim, their eyes, hands, and expertise stay in the process. We can support this journey with phase-appropriate controls, GXP specialists, and rapid installation of real-world metrics. Our focus on readiness and reliability will position your team for rapid growth, scale-up, and consistent product.
