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Head of GMP Operations for Cell Therapy
2 months ago
Senior Director of Cell Therapy Manufacturing
Location: Not Specified
Our client is at the forefront of developing cutting-edge facilities dedicated to the research and production of transplantable cell therapy solutions. They have established themselves as pioneers in advanced cancer treatments and are committed to further innovations in the oncology sector.
The Senior Director of Cell Therapy Manufacturing will be responsible for ensuring the quality and safety of all products produced in the laboratory. This role encompasses the production of cell therapy products that adhere to federal regulations (including FDA), industry standards, and the guidelines set forth by the Foundation for the Accreditation of Cellular Therapy (FACT).
Key Responsibilities:
- Manage the daily operations of the laboratory, overseeing both investigational and non-investigational products, product pipelines, development, delivery, analysis, quality assurance (QA) testing, and reporting of outcomes.
- Supervise the processing, manufacturing, development, testing, storage, and distribution of cell therapy products.
- Ensure that cellular therapy products released from the laboratory meet the clinical and quality standards necessary for infusion in both standard care and clinical trial environments.
- Develop and implement standard operating procedures (SOPs) to maintain operational excellence.
- Lead various departments (TCT, GMP, and storage) within the laboratory to fulfill operational requirements and formulate business strategies to support laboratory projects.
- Maintain laboratory operations in compliance with current FACT and Good Manufacturing Practice (cGMP) standards as mandated by regulatory and accrediting bodies.
- Collaborate with the Laboratory Director on grant proposals and initiatives related to the TCT-GMP lab.
- Engage daily with the clinical team to make critical decisions that ensure the highest quality products align with patient treatment plans, while also coordinating with other facility users.
Qualifications:
- A Bachelor's degree in Biological Science or Clinical Laboratory Science is required.
- A Master's degree in life sciences (e.g., Biologics or Pharmaceutical) or a PhD, MD (or equivalent) in a relevant scientific field is preferred.
- A minimum of five years of experience (preferably in a leadership role) in a Transplant Cell Therapy GMP laboratory or a related academic or industrial environment (e.g., cellular or biological manufacturing, process development, and analytical methods) is required.
- Familiarity with Hematopoietic Progenitor Cells/Immune Effector Cells, as well as other cellular products and viral production laboratory processes.
- Comprehensive understanding of Good Manufacturing Practices (cGMPs, GLPs, GDPs) and cellular and gene therapies.
- Knowledge of federal and state regulations, including FDA and FACT, along with theoretical and technical principles related to transplant cell therapy laboratory operations and GMP process management.
- Solid understanding of cell processing, viral production, immunology, cell biology, hematology, and cell product banking.
- Commitment to staying current with advancements in the field of cellular therapy.
