Associate Director, Chemical Development

Role: Associate Director of Chemical Development overseeing drug substance CMC activities from preclinical to commercial stages. Responsibilities: manage API operations at CMOs, ensure manufacturing aligns with regulatory and project goals, lead technology transfer, process development, validation, and supply strategies; support regulatory submissions; review manufacturing documentation; oversee on-site or remote technical oversight; develop budgets and collaborate on CMC strategies. Requirements: Ph.D. in a relevant scientific or engineering field with 8+ years or B.S. with 12+ years, experience in pharmaceutical manufacturing/support, especially in small-molecule APIs, process development, and CMO oversight; strong project management, cross-functional leadership, and communication skills. High-Value: drug substance development, biologics or small molecules, CMC regulatory environment, experience with sterile products preferred, international supply chain, travel up to 30%. Work Setup: hybrid Irvine, CA; some travel required.