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

Role

Associate Director leading global external manufacturing for large molecule (LM) drug substances in animal health, focusing on viral products and network transfers.

Responsibilities

• manage LM drug substance portfolio across CMO network, oversee tech transfer, process development, process improvement, troubleshooting, and lifecycle management;
• lead supplier technical management, conduct audits, and support global sourcing;
• ensure timely delivery, manage deviations, and drive innovation to optimize processes and reduce costs. Collaborate with cross-functional teams including procurement, Quality, R&D, and manufacturing;
• lead technical due diligence, develop technical packages, and support regulatory strategies.

Requirements

• Bachelor's in Biochemistry, Bioprocess Engineering, or similar;
• 10+ years in biopharma, with at least 5 years in LM process development, including viral vaccines and monoclonal antibodies;
• strong project management, leadership, and communication skills;
• experience with global CMOs, process scale-up, and regulatory compliance (US/EU).

Preferred

• PhD
• Six Sigma/PMP certification
• deep process troubleshooting expertise
• CMO audit experience.

High-Value

• biologics and viral vaccine development
• process transfer for in-line supply
• cross-continental coordination
• regulatory strategy expertise.

Work setup: hybrid with 15-20% travel.