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

Role: Large Molecule drug substance leader managing external manufacturing for viral products within a global CMO network, focusing on process transfer, development, scale-up, and lifecycle management, primarily in the commercial space. Responsibilities include leading technical transfer projects, overseeing supplier relationships, conducting audits, supporting process improvements, troubleshooting, and ensuring supply continuity. The role requires partnering with cross-functional teams across Science & Technology, Quality, Procurement, and manufacturing to deliver end-to-end project execution, including supplier selection, due diligence, and innovation initiatives. Essential duties involve managing supplier technical relationships, overseeing process changes, deviations, and system improvements, and leading cross-company technical meetings. Qualifications: Bachelor’s degree in Biochemistry, Bioprocess Engineering, or related field; minimum 10 years of relevant experience, including 5+ years in LM process development, with expertise in viral vaccines, monoclonal antibodies, ADCs, mRNA, and related bioprocesses. Preferred: PhD with 7+ years, deep process scale-up knowledge, and regulatory familiarity (FDA, USDA, EU). Core skills cover biologics, GMP, process development, tech transfer, vendor evaluations, and project management, with a focus on external manufacturing and process scale-up. The position involves global collaboration, frequent travel (~15-20%), and hybrid work, emphasizing technical leadership, strategic thinking, and stakeholder management in a highly regulated biotech environment.