Development - Quality by Design

Accelerate Your Path from Discovery to Clinic

Dr. Irwin of RedRock BPC brings over a decade of leadership in biologics development, with a consistent focus on strategic, phase-appropriate planning that enables rapid clinical entry. With deep academic and industry experience in bioreactor design, upstream optimization, and cell-based production systems, we can help you translate complex science into decisive development strategies in an FDA-friendly Quality by Design format.

Holding advanced degrees in Medicine (immunology/microbiology), Cell Biology, and Business, Dr. Irwin has built and executed robust GxP systems tailored to each phase of development. His expertise spans external manufacturing, supplier qualification, outsourcing strategy, and risk-based controls, ensuring technical operations are ready to scale under regulatory pressure.

With proven leadership in cross-functional environments, our team excels at uniting clinicians, scientists, and executives under clear development goals. Our tools help lead the formation of elite bioprocess teams by fostering trust, transparency, and accountability through active management and real-time metrics.

Whether your organization needs early-stage planning, CMC strategy, or a trusted partner to guide external partnerships, RedRock delivers the insight and structure needed to move with confidence.

Ready to move forward? Let’s plan your development pathway with speed, clarity, and compliance.