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Director of Cellular Immunotherapy GMP Manufacturing
Job Details
- Job Ref:
- 10033169
- Location:
- Duarte, CA 91009
- Category:
- Cell Manufacturing
- Job Type:
- Full-time
- Shift:
- Days
- Pay Rate:
- $86.07 - $143.74 per hour
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.
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
Qualifications
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, please CLICK HERE.