Our client is building a state-of-the-art facility for the research and production of transplantable cell therapy products. They are already well established as a leader in advanced cancer therapies and are looking to continue to innovate within the oncology field.
The Director of Cell Therapy GMP Operations will ensure the quality and safety of all products manufactured through the lab. The position is responsible for producing cell therapy products that comply with federal (including FDA), industry, and Foundation for the Accreditation of Cellular Therapy (FACT) standards and regulations.
Responsibilities:
Oversee the day-to-day operations of that lab, including non-investigational and investigational products, product pipelines, product development, delivery, product analysis, quality assurance (QA) testing, outcomes monitoring and reporting.
Supervise the processing, manufacturing, process development, testing, storage, distribution of cell therapy products.
Ensures that cellular therapy products released by the laboratory meet clinical and quality criteria for infusion in the standard of care and clinical trial settings.
Responsible for the development and implementation of standard operating procedures (SOPs).
Direct the various departments (TCT, GMP, and storage) of the lab to meet operational needs and develop business plans to support the projects of the laboratory.
Maintain and operate the laboratory with current FACT and Good Manufacturing Practice (cGMP) practices as specified by FACT, FDA and similar regulatory and accrediting entities.
In collaboration with the Director of the Laboratory, will participate in grants and proposal writing as it relates to TCT-GMP lab.
Collaborate daily with clinical team to make critical decisions resulting in the highest quality products that meet the patient's treatment plan as well as with other various users of the facility.
Qualifications:
Bachelor's degree in a Biological Science or Clinical Laboratory Science required.
Master's degree in the life sciences (e.g. Biologics or Pharmaceutical), or PhD, MD (or equivalent) degree in a related scientific discipline preferred.
Five years of experience (leadership experience preferred) in a Transplant Cell Therapy GMP lab or in a related academic or industrial setting (e.g. cellular, biological manufacturing experience, process development and analytical methods) required.
Knowledge of Hematopoietic Progenitor Cells/Immune Effector Cells, other cellular products and viral production laboratory processing.
Understands Good Manufacturing Practices (cGMPs, GLPs, GDPs) and cellular and gene therapies.
Knowledge of federal and state regulations, such as FDA and FACT, and theoretical and technical principals related to transplant cell therapy laboratory and GMP process implementation and maintenance.
Understanding of cell processing, viral production, immunology, cell biology, hematology and cell products banking.
Remain up to date with literature in the field of cellular therapy.