Carrières

Research and Development
Manufacturing
Regulatory Affairs
Industrial Property
Clinical Development

Researcher

Researchers are high-level scientists who specialize in a specific field. A researcher manages one or more projects and works with a team to draw up and carry out experimental protocols, as well as to analyze and interpret the results. Researchers showcase their results and present technological developments to the scientific community by publishing and participating in colloquia. They are also named as inventors in a significant number of patents and patent applications. Researchers are experts in their fields and work actively to stay abreast of the latest scientific developments.

Engineer

Engineers report directly to researchers. They are technology experts who participate in projects by designing and carrying out experiments, as well as analyzing results. Engineers know the possibilities and limits of the techniques being used, and can share their expertise with colleagues.

Technician

Technicians work under the supervision of a researcher or engineer. They perform experiments and are in charge of correctly implementing protocols and managing results.

Preclinical development

The goals of preclinical studies are to demonstrate the anti-tumor activity of the UCART product candidates, to study their mechanism of action and to assess their potential toxicity following administration to patients. Those studies are conducted both in vitro and in vivo in animal models in association with a risk-benefit analysis performed in the context of the particular clinical indication under study. Preclinical studies are part of the Investigational New Drug application in the U.S. or Clinical Trial Authorization application in the U.K. and the Marketing Authorization application.

Quality Assurance

The quality assurance team defines and coordinates the implementation of the company’s quality policy. A quality system is set up by adapting to each product development phase: Research & Development, CAR Development and Process Development, then manufacturing for clinical and commercial use. This quality assurance system should guarantee that baselines such as Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP) are followed. Quality assurance is based on a manual defining policies to be observed, as well as procedures to follow in case of non-compliant results, for instance.

Working closely with the scientific and regulatory affairs teams, the Quality Assurance department ensures the homogeneity of documentation relating to product development and ensures compliance with standards and regulations in case of technology evolutions.

Manufacturing

GMP, (Good Manufacturing Practices) are a set of regulations applicable to the manufacturing of health products, especially medicines intended for human use, such as UCART products. A company is required to comply with GMP regulations in order to be granted a license from governmental regulatory agencies to manufacture pharmaceutical products. The Manufacturing department takes manufacturing processes established at the R&D level, converts them to GMP, and ensures their deployment with GMP compliant raw materials and environments. The department is responsible for the manufacturing of clinical trial material (“CTM”), making it available for clinical studies and afterwards, and also for the manufacturing of final GMP commercial cellular gene therapy products. The team interacts internally with different departments and groups ranging from development and planning, to regulatory and legal, as well as externally as the Cellectis contact point for the raw materials contractors or the GMP manufacturing contract organizations.

Regulatory Affairs

The regulatory affairs team is in charge of ensuring that drug candidates’ development is carried out according with the applicable rules, regulations and directives. In order to do so, the regulatory team works closely both with scientists and the legal department, internally collecting and formalizing information to elaborate the drug candidates’ development plan. It is essential to comply with regulatory requirements as well as scientific criteria, since content and format are equally important. This team also acts as an interface with regulatory agencies, with whom they work while preparing and producing files.

Patent engineer

Intellectual property is very important to Cellectis. The Group invests more than half its budget in research and development in order to fine-tune new gene editing techniques. An in-house team of patent engineers, in conjunction with external European and U.S. patent law firms, is responsible for writing patent applications. Our patents concern reagents used to cut DNA and their various applications in gene editing, such as modified immune cell lines, and new plant varieties. Many of our patents have been licensed to other companies, which helps leverage our intellectual property and can foster potential collaboration agreements. Cellectis has also acquired licenses for the right to implement other people’s patents, deemed useful to the Company by our patent department.

Clinical Development

The clinical development team is in charge of building the clinical strategy for the development of our gene edited CAR-T cells and other therapies in the field of immune-oncology, but also gene editing based approaches in non-malignant diseases. The clinical development team works closely with the pre-clinical development and the translational teams, as well as the regulatory department, to develop and implement clinical programs, evaluate the safety profile of our products and check that GCP (Good Clinical Practice) procedures are met as required. The team has established strong relationships with the scientific and medical community in order to develop new therapeutic strategies for the treatment of diseases, especially in indications with a high medical need. The clinical and translational teams understand the importance of clinical investigations for the effective introduction and acceptance of these new therapies and design the clinical trials accordingly. The clinical development department also drives collaborations with our industrial and academic partners in terms of medical science and clinical projects.