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.
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.
Qualifications
- 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, please CLICK HERE.