Associate Director, Analytical Method Expert (AS&T Lifecycle Management) | Pharmacist (m/w/d)

Job Summary

This Associate Director role focuses on providing critical analytical expertise to support the late-stage and commercial development of RNA and Protein-based therapeutic pipelines. The successful candidate will act as the main point of contact for specific analytical methods, ensuring strict compliance with GMP standards to deliver accurate and reliable results. Key responsibilities include managing method validation, transfer strategies, and lifecycle activities, such as critical reagent exchange and performance monitoring. You will actively participate in cross-functional CMC team discussions and be responsible for the timely evaluation and review of technical and regulatory submission documents (BLA/MAA). This position requires an advanced scientific degree, over five years of industry experience in CMC development, and deep, hands-on knowledge of various analytical techniques, including HPLC, mass spectrometry, and immunoassays, making a significant impact on product approval and market launch.