Principal Scientist CMC Analytical Development | Principal Scientist CMC Analytical Development (alle Geschlechter)

Job Summary

This Principal Scientist role in CMC Analytical Development involves leading analytical projects for drug products, guiding them from early clinical trials through to market commercialization. The core responsibilities include ensuring strict adherence to ICH guidelines and GMP standards, serving as a Subject Matter Expert (SME) to provide scientific and technical guidance, and driving complex projects within multidisciplinary CMC teams. Day-to-day tasks involve developing and validating modern analytical methods (especially HPLC and LC-MS), defining specifications, transferring methods to external partners, and preparing regulatory submissions. Candidates must possess a PhD in Analytical Chemistry or a related field, coupled with significant pharmaceutical industry experience focused on Drug Product analytics. Success requires a structured, solution-oriented approach, strong project management skills, and fluency in both German and English, contributing actively to innovation and efficiency within the analytical cluster while mentoring junior scientists.