Senior Manager, Protein Sciences Downstream

Responsibilities

• Act as subject matter expert in protein purification, drug product formulation, fill, and lyophilization
• Manage GMP manufacturing operations and contracted manufacturing operations (CMOs)
• Oversee process development, transfer, scaleup, validation, and COGS improvements
• Support regulatory CMC and registrational activities, particularly for ex-US operations
• Liaise with Quality and Supply Chain on product disposition, technical investigations, and CAPAs
• Manage technical information flows, project milestones, and support site audits
• Ensure CMO site operational readiness for manufacturing campaigns and process transfers

Requirements

• Minimum 9 years experience with a Bachelor's, 7 years with a Master's, or 4 years with a PhD in a Life Science discipline
• In-depth understanding of protein purification, characterization, drug product formulation, fill, and lyophilization
• Strong operational experience in a GMP manufacturing environment
• Direct experience managing Contract Development and Manufacturing Organizations (CDMOs)
• Thorough understanding of biotherapeutics manufacturing
• Ability and willingness to travel globally for extended periods

About the Company

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer, harnessing the human immune system to attack diverse cancer cells.