Louisville, CO30+ days ago
Drive statistical strategies for establishing process and product specifications, comparability efforts when needed, including contributing to risk assessments, investigations and information requests with potentially direct interface with FDA/EMA statisticians during regulatory reviews. We are a diverse and growing team working in brand-new facilities in downtown Seattle, Washington and Louisville, Colorado, and we are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting-edge drug development.