Executive Director, Technical Operations

RPMGlobal; 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 a clinical-stage biotechnology company advancing a pipeline of next-generation immuno-oncology therapies designed to activate the immune system against cancer. Our lead programs include botensilimab (BOT), a multifunctional next-generation CTLA-4 antibody, and balstilimab (BAL), an anti-PD-1 antibody, which are being developed across multiple tumor types.

As our programs continue to advance through clinical development, we are seeking an experienced Technical Operations leader to help drive the technical development and manufacturing strategy required to support their continued development and potential commercialization.

Position Overview

Agenus is seeking a Director / Executive Director, Technical Operations to provide technical and operational leadership across the development and manufacturing of our biologics pipeline. This individual will serve as a key internal leader for technical development and manufacturing strategy and execution, providing scientific and technical leadership across process development, analytical development, formulation, technology transfer, and external manufacturing.

This individual will serve as a critical technical bridge between Research/Development and manufacturing, ensuring effective knowledge transfer and translation of development processes into robust, scalable manufacturing processes.

With manufacturing executed through CDMO partnerships, including Zylidac Biologics LLC, this individual will serve as a primary technical interface between Agenus and its manufacturing partners. The Director / Executive Director will ensure that external manufacturing activities are aligned with Agenus's clinical, regulatory, quality, supply, and commercialization objectives. This individual will serve as the key CMC interface for CMC submissions to US FDA, EU and other regulatory agencies.The position will be responsible for answering information requests related to all Agenus pipeline programs including final executive review of CMC Module 3, INDs, IMPDs and other dossiers prior to publishing.The position will provide oversight of CDMO activities including serving on CDMO governance such as JPT and JSC.

This is a highly cross-functional and hands-on leadership role for someone who can set strategy while remaining close to execution, identify and resolve technical risks, and drive complex programs forward in a fast-paced biotechnology environment.

Key Responsibilities

• Provide strategic and technical leadership for Technical Operations and manufacturing activities supporting Agenus biologics programs from clinical development through commercialization.
• Serve as an internal technical owner for manufacturing activities performed by CDMO partners, including Zylidac Bio.
• Establish effective governance and working relationships with CDMOs, ensuring clear expectations, accountability, timelines, technical standards, and escalation of risks.
• Provide scientific and technical leadership across process development, including upstream and downstream process sciences, analytical development, formulation, drug substance, and drug product, ensuring development activities support successful scale-up and manufacturing.
• Serve as the technical bridge between Research/Development and manufacturing partners, ensuring effective transfer of process and product knowledge throughout development.
• Develop and execute phase-appropriate technical development and manufacturing strategies aligned with clinical development plans and corporate priorities.
• Lead technology transfer from development into manufacturing or CDMO, ensuring process knowledge, analytical methods, critical process parameters, product quality attributes, and technical risks are effectively transferred to Agenus West and other manufacturing partners.
• Oversee process scale-up, process characterization, validation, manufacturing readiness, and commercialization planning.
• Provide technical oversight of manufacturing campaigns and partner with CDMOs to troubleshoot process, analytical, quality, and manufacturing issues.
• Evaluate manufacturing performance, capacity, capabilities, timelines, and technical risks and develop appropriate mitigation strategies.
• Partner closely with Quality, Regulatory Affairs, Clinical Operations, Supply Chain, Project Management, and other internal stakeholders to ensure alignment across development programs.
• Provide technical and scientific input to CMC regulatory submissions, including Module 3, and support responses to health authority questions and regulatory interactions as needed.
• Ensure manufacturing and development activities are conducted in accordance with applicable GMP requirements, ICH guidelines, and global regulatory expectations.
• Identify and evaluate new technologies, platforms, and development approaches that can improve process robustness, speed, scalability, and manufacturing efficiency.
• Drive continuous improvement across development and manufacturing processes, identifying opportunities to improve robustness, scalability, efficiency, and speed.
• Develop and manage Technical Operations budgets, resource plans, program timelines, and external partner activities.
• Represent Technical Operations on cross-functional program teams and communicate technical strategy, progress, risks, and recommendations to senior leadership.
• Provide scientific and technical leadership across the organization and mentor and develop technical team members as appropriate.
• Collaborate with head of Commercial, Clinical Operations and CDMO partnersto develop both short and long range forecast for all pipeline to ensure no supply risk

Qualifications

• BS, MS, or PhD in Chemical Engineering, Biochemistry, Biotechnology, Pharmaceutical Sciences, or a related scientific discipline.
• 12+ years of relevant biotechnology or pharmaceutical industry experience, with level determined based on experience and scope of prior leadership.
• Significant experience in biologics development and manufacturing, preferably including monoclonal antibodies, bispecific antibodies, or other complex biologic molecules.
• Broad technical knowledge across upstream and downstream process development, analytical development, formulation, drug substance, and drug product.
• Demonstrated experience translating development-stage processes into scalable manufacturing processes, including technology transfer and knowledge transfer to manufacturing organizations or external partners.
• Demonstrated experience overseeing external CDMOs/CMOs, including technical governance, manufacturing execution, technology transfer, scale-up, and troubleshooting.
• Experience supporting programs through multiple stages of clinical development, with late-stage development, process characterization, PPQ, validation, and commercialization experience strongly preferred.
• Strong working knowledge of GMP, ICH guidelines, FDA, EMA, and other global regulatory requirements.
• Experience providing technical CMC support for IND, IMPD, BLA and/or MAA filings and regulatory interactions.
• Proven ability to lead complex cross-functional initiatives and influence stakeholders without direct authority.
• Strong technical judgment and problem-solving skills, with the ability to identify risks and drive issues through resolution.
• Demonstrated ability to operate both strategically and hands-on in a fast-paced, evolving biotechnology environment.
• Leadership and people-management experience appropriate to the Director or Executive Director level.

Preferred Experience

• Experience with antibody and/or immuno-oncology product development.
• Experience transitioning biologics programs from clinical development toward commercial manufacturing.
• Experience managing complex CDMO relationships and outsourced manufacturing models.
• Experience with process characterization, PPQ, validation, comparability, and commercial readiness.
• Experience working across global development and manufacturing networks.

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