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

Role: Associate Director, Large Molecule Drug Substance Lead, managing external manufacturing and process transfer for viral and monoclonal antibody products within the biotech pipeline. Responsibilities include overseeing tech transfer, process development, process optimization, troubleshooting, and lifecycle management of LM drug substances—primarily viral vaccines and biologics—across global CMOs, with a focus on the US market and in-line supply. The role involves supplier qualification, technical due diligence, change management, and cross-functional collaboration with procurement, Quality, R&D, and manufacturing teams. The individual leads technical projects from sourcing through commercial supply, ensuring quality, compliance, cost-efficiency, and innovation, especially for network transfers of viral products. Key duties include managing supplier relationships, conducting audits, leading process validation and change initiatives, and supporting regulatory compliance in US/EU. Qualifications: Bachelor’s in Biochemistry, Bioprocess Engineering, or related field; minimum 10 years in biopharma, with 5+ years in LM process development—preferably viral vaccines, monoclonals, ADCs, mRNA; proven project leadership, technical expertise, and global supply chain management skills. Preferred: PhD, extensive experience with process scale-up, troubleshooting, CMO management, and regulatory strategies. Skills in GMP, tech transfer, process development, vendor evaluation, and project management tools. Travel requirement: 15–20%; work setup: hybrid, US-based with global responsibilities.