Executive Director, Technical Operations – Biologics

Agenus Inc.; Lexington (MA); Hybrid; USD 180,000 - 280,000; Full time

Job summary

Agenus is seeking a Director / Executive Director, Technical Operations to provide leadership across development and manufacturing of its biologics pipeline. You will guide process development, analytical development, formulation, and transfer to external manufacturing partners, ensuring alignment with clinical and regulatory goals.

The role bridges R&D and manufacturing, driving scalable, robust processes, technology transfer, and external partnerships while ensuring GMP compliance and

Qualifications

• BS, MS, or PhD in Chemical Engineering, Biochemistry, Biotechnology, or a related scientific discipline.
• 12+ years of biotech or pharmaceutical leadership experience.
• Experience leading external CDMOs/CMOs and governance structures.
• Strong GMP/ICH knowledge and regulatory submission support.

Responsibilities

• Provide strategic and technical leadership for Technical Operations from clinical development to commercialization.
• Oversee CDMO relationships, governance, timelines, and risk escalation.
• Lead process development, analytical development, formulation, and tech transfer.
• Act as technical bridge between R&D and manufacturing for knowledge transfer.
• Develop phase-appropriate development and manufacturing strategies aligned with plans.
• Lead technology transfer and ensure capabilities transfer to manufacturing partners.
• Oversee scale-up, validation, readiness, and commercialization planning.
• Coordinate with Quality, Regulatory, Clinical Ops, and Supply Chain to align programs.
• Support CMC regulatory submissions and responses to health authorities.
• Ensure GMP compliance and identify opportunities for improvement.

Skills

Leadership

Cross-functional collaboration

Regulatory knowledge

Education

BS/MS/PhD in Chemical Engineering, Biochemistry, Biotechnology, or related field

Job description

Agenus is seeking a Director / Executive Director, Technical Operations to provide leadership across development and manufacturing of its biologics pipeline. You will guide process development, analytical development, formulation, and transfer to external manufacturing partners, ensuring alignment with clinical and regulatory goals.

The role bridges R&D and manufacturing, driving scalable, robust processes, technology transfer, and external partnerships while ensuring GMP compliance and