Head of GMP Operations for Cell Therapy

2 weeks ago

Loma Linda, California, United States HireMinds Full time

Senior Director of Cell Therapy Manufacturing

Location: Confidential

Our organization is developing a cutting-edge facility dedicated to the research and production of transplantable cell therapy products. As a recognized leader in advanced cancer treatments, we are committed to driving innovation 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 entails overseeing the production of cell therapy products that adhere to federal regulations, 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, encompassing both investigational and non-investigational products, product pipelines, development, delivery, analysis, quality assurance (QA) testing, and outcomes monitoring.
  • 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 required for infusion in both standard care and clinical trial environments.
  • Develop and implement standard operating procedures (SOPs) to maintain compliance.
  • Lead various departments (TCT, GMP, and storage) to fulfill operational requirements and formulate business strategies to support laboratory projects.
  • Maintain laboratory operations in accordance with current FACT and Good Manufacturing Practice (cGMP) standards as dictated by regulatory and accrediting bodies.
  • Collaborate with the Laboratory Director on grant writing and proposals related to the TCT-GMP lab.
  • Work closely with the clinical team to make critical decisions that ensure the highest quality products align with patient treatment plans, while also engaging 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, other cellular products, and viral production laboratory processes.
  • 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 implementation.
  • Comprehensive understanding of cell processing, viral production, immunology, cell biology, hematology, and cell product banking.
  • Stay current with the latest literature in the field of cellular therapy.

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