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

Jobleads-US

Millsboro, DE

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.

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Vacancy posted 4 days ago
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