Assoc. Dir - Large Molecule External Manufacturing Technology, Network & Viral Lead

Role: Associate Director of Large Molecule (LM) Drug Substance, responsible for managing external manufacturing projects within the global CMO network, focusing on viral products and process transfer, development, scale-up, and lifecycle management. Responsibilities include leading cross-functional teams for sourcing, technical transfer, process improvement, troubleshooting, and supplier oversight; conducting supplier due diligence and audits; managing deviations and process changes; and driving innovation to optimize processes and reduce costs. The role entails end-to-end project management from R&D to commercial supply, with a key focus on network transfers for viral biologics such as mRNA, monoclonal antibodies, and vaccine antigens. Collaborates with network teams, procurement, quality, regulatory, and internal manufacturing units to ensure supply continuity and compliance. Core requirements include a Bachelor's degree in Biochemistry, Bioprocess Engineering, or related field, with at least 10 years of relevant industry experience, including 5+ years in LM process development and viral vaccine development. Preferred qualifications encompass a PhD, deep expertise in process scale-up, trouble-shooting, and regulatory strategies (FDA/USDA/EU). Strong leadership, project management, communication skills, and experience with GMP, technology transfer, and global CMO oversight are essential. The role is based in a hybrid work setup, with approximately 15-20% travel, predominantly supporting viral biologics manufacturing in the US and globally.