Director of Technical Operations - Biologics

Agenus

Lexington (MA)

On-site

USD 180,000 - 260,000

Full time

5 days ago

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Benefits offered by this job

Medical, Dental & Vision Coverage

401(k) Match

Employee Stock Purchase Plan

Education Assistance Program

Flexible Vacation Plan

Care.com Memberships

Employee Assistance Program

Job summary

Agenus is seeking an experienced Director/Executive Director, Technical Operations to lead development and manufacturing strategy for our biologics pipeline. This role bridges R&D and manufacturing, guiding process development, analytical development, formulation, and technology transfer through CDMO partnerships.

You will oversee scale-up, validation, and readiness, while ensuring GMP compliance and strategic alignment with regulatory and commercial goals.

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.

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 partners to develop both short and long range forecast for all pipeline to ensure no supply risk.