Associate Director, CMC Lead

Role: Associate Director, CMC Lead, responsible for defining and executing early-stage CMC development strategies for alpha-emitting, tumor-targeted radioconjugates. Core responsibilities include leading pre-IND/IND-enabling activities, managing API, drug product, and analytical development, and coordinating clinical supply strategies for Phase 0/I trials. The role involves cross-functional collaboration with regulatory, research, quality, and supply chain teams to facilitate seamless candidate progression. Requirements: 7+ years in pharmaceutical/biopharma product development and manufacturing; Bachelor's degree required, advanced science degrees preferred; experience in early-phase CMC development, IND-enabling activities, and process/analytical method development. Preferred skills include radiopharmaceutical knowledge, radiochemistry awareness, and experience with complex modalities such as biologics or conjugates. High-Value: focus on radioconjugates in oncology, early development stages, with responsibilities spanning regulatory strategy, clinical supply, and portfolio management; familiarity with radiochemistry constraints and short half-life product logistics is advantageous. Work setup: not specified; position involves leadership in a dynamic, matrix environment.