Director of Cellular Immunotherapy GMP Manufacturing

Join the forefront of groundbreaking research at theBeckman 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.

As a successful candidate you will:

* 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

Your qualifications should include:

* 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).

City of Hope employees pay is based on the following criteria: work experience, qualifications, and work location.

City of Hope is an equal opportunity employer.

To learn more about our Comprehensive Benefits, pleaseCLICK HERE.