The Role: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.
Key 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.
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 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.
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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Learn More About AgenusExplore our innovative pipeline and connect with us on LinkedIn.Why You'll Love Working at AgenusWe're proud to offer a comprehensive and inclusive benefits program designed to support your well-being, growth, and life outside of work:
- Medical, Dental & Vision Coverage - Competitive options for both US & UK employees
- Flexible Spending Accounts - For healthcare and dependent care expenses (US)
- Flexible Vacation Plan - We believe time away leads to better thinking and innovation.
- Care.com Memberships - Support for family care (US)
- Education Assistance Program - Invest in your learning and development (US)
- 401(k) Match
- Employee Stock Purchase Plan
- Employee Assistance Program (EAP) - Resources for mental health, well-being, and life support
- Reward & Recognition Program - Celebrate contributions that move the mission forward
