Executive Director, Technical Operations

Agenus Inc.•Lexington, MA

About The Position

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 CMC and manufacturing strategy required to support their continued development and potential commercialization. Agenus is seeking a 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 CMC strategy and execution, overseeing activities spanning process development, analytical development, formulation, drug substance, drug product, and manufacturing. With manufacturing executed through CDMO partnerships, this individual will serve as a primary technical interface between Agenus and its manufacturing partners. The Executive Director will ensure that external manufacturing activities are aligned with Agenus's clinical, regulatory, quality, supply, and commercialization objectives. 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.

Requirements

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 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, validation, and commercialization experience strongly preferred.
Strong working knowledge of GMP, ICH guidelines, FDA, EMA, and other global regulatory requirements.
Experience supporting 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.

Nice To Haves

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.

Responsibilities

Provide strategic and technical leadership for CMC and Technical Operations activities supporting Agenus biologics programs from clinical development through commercialization.
Serve as an internal technical owner for manufacturing activities performed by CDMO partners, including Agenus West.
Establish effective governance and working relationships with CDMOs, ensuring clear expectations, accountability, timelines, technical standards, and escalation of risks.
Lead and integrate activities across upstream and downstream process development, analytical development, formulation, drug substance, and drug product.
Develop and execute phase-appropriate CMC and manufacturing strategies aligned with clinical development plans and corporate priorities.
Oversee process scale-up, technology transfer, 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 CMC input into IND, IMPD, BLA, MAA, and other global regulatory submissions and agency interactions.
Ensure manufacturing and development activities are conducted in accordance with applicable GMP requirements, ICH guidelines, and global regulatory expectations.
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.