**Job Title: Associate Director**
The Associate Director is responsible for guiding the execution of Quality Control (QC) processes and shaping the program-level strategy for assigned programs and external testing partners throughout the phases of development, from Phase 1 through to commercialization. This role involves collaboration across various functions to guarantee the compliant execution of QC tasks, which encompass release and stability testing, management of method lifecycles, and support for regulatory submissions. Ideal candidates should possess 8-12+ years of experience in a relevant scientific area with a robust technical foundation in analytical methods related to biologics. A thorough comprehension of current Good Manufacturing Practices (cGMP), International Council for Harmonisation (ICH), FDA, and European Medicines Agency (EMA) guidelines is essential, along with experience in managing external collaborators such as Contract Development and Manufacturing Organizations (CDMOs).
