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

Role: Associate Director of Large Molecule Drug Substance responsible for managing external manufacturing activities within our global CMO network, focusing on viral product process transfer, development, and lifecycle management. Responsibilities include leading cross-functional projects such as sourcing, process transfer, process improvement, troubleshooting, and innovation for LM drug substances, particularly viral products. The role involves strategic planning, technical leadership during tech transfer, process development, and commercialization, as well as supplier management, audits, and change control. Collaboration with internal teams (Quality, Regulatory, Supply Chain, R&D) and external suppliers is key. The individual will oversee supply chain integrity, manage deviations, and drive process innovations to optimize efficiency and cost. The position demands high-level project management, stakeholder communication, and leadership skills to ensure on-time delivery of high-quality drug substances. Qualifications include a Bachelor's in Biochemistry, Bioprocess Engineering, or related field, with at least 10 years of relevant experience, including 5+ years in LM process development, and experience with viral vaccines and biologics like monoclonal antibodies, mRNA, or ADCs. Preferred qualifications include a PhD, expertise in process scale-up, CMO management, and knowledge of US/EU regulatory strategies. The role is global with significant travel (15-20%), hybrid work, and a focus on continuous process innovation within bioscience manufacturing.