Director of Cellular Immunotherapy GMP Manufacturing

City of Hope•Duarte, CA

53d

About The Position

Join the forefront of groundbreaking research at the Beckman Research Institute of City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. Our dedicated and compassionate faculty and staff are driven by a common mission: Contribute to innovative approaches in predicting, preventing, and curing diseases, shaping the future of medicine through cutting-edge research. We are looking for a leader to head the Manufacturing of Cellular Immunotherapies in Cell and Gene Therapy Operations. This role reports to the Vice President of Cell and Gene Therapy Operations / Director of the Center for Bioinnovation and Manufacturing. COH has a mission to transform the future of cancer care. In support of this mission, COH has over 20+ years of experience in GMP production of Cell and Gene Therapies holding >120 active INDs and supported by an 80+ person GMP team. The new Director will oversee a Manufacturing team of >15 people that focuses primarily on autologous production of >60 CAR-T therapies per year in support of early clinical trials. Additional relevant areas of expertise are manufacturing of TILs and CAR-NK.

Requirements

Bachelor’s degree in biological sciences, engineering, or related field (Masters or PhD preferred).
Minimum of 5 years of experience working with human T-cells, primary human cells, immune systems or similar biological systems.
Minimum of 2 years of experience in cGMP cell therapy and/or biological product manufacturing, ideally with immunoeffector cell therapy focus.
Minimum of 2 years supervisory experience and leading teams of greater than 5 people in a highly matrixed and milestone-driven environment.
Strong understanding of CAR-T biology, including T-cell activation, cytotoxicity, and exhaustion.
Strong Interpersonal and collaboration skills to interface with external groups.
In-depth knowledge of cGMP regulations and FDA guidance for biologics and cell therapy.
Experience in regulatory documentation (e.g., FDA CMC submissions).

Responsibilities

Lead and manage a high-performing team responsible for cGMP manufacturing of cellular immunotherapy products.
Ensure execution of manufacturing processes that meet rigorous safety, quality, and compliance standards.
Oversee GMP manufacturing logistics, including scheduling, resource allocation, and throughput optimization.
Troubleshoot and resolve issues, identify root causes, and implement process improvements with clear communication to senior leadership and project PIs.
Develop and monitor KPIs for productivity, efficiency, and compliance.
Drive continuous improvement initiatives, leveraging advanced technologies and best practices.
Ensure adequate staffing, facilities, equipment, and documentation to meet evolving priorities and capacity needs.
Collaborate with internal stakeholders to align manufacturing operations with institutional goals.
Partner with Project Management to develop budgets for internal and external projects.
Recruit, train, and mentor team members, fostering professional growth and career development.
Establish organizational structure, policies, and production schedules to support operational excellence.
Promote a culture of collaboration, accountability, and innovation