Janssen Vaccines & Prevention, previously Crucell, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is dedicated to bringing meaningful innovation to global health. Our teams focus on the discovery, development, manufacture and marketing of vaccines and antibodies to protect people worldwide from infectious diseases.
In our organization entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points. In order to strengthen our team we are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Janssen.Department:
The Clinical Immunology department is responsible for the immunological evaluation of vaccine candidates in clinical trials. In close collaboration with the Biomarker group and clinical development group, the clinical immunology department executes the immuno strategies and ensures the development, and validation of the required immunological assays as well as clinical sample analysis and data reporting. Typical assays to determine the immunogenicity of vaccines are the antibody ELISA, T cell ELISpot, Intracellular Cytokine Staining, and virus neutralization assays. The clinical immunology department offers Janssen Vaccines with services in Scientific and operational excellence, with high standards of quality and compliance.Job Description:
The main responsibility of the Senior Scientist will b to guarantee the correct design and execution of experiments for the development and validation of immunological assays to be used in the analysis of samples from clinical trials for multiple programs within time and budget. The initial focus will be on assays in support of our Coronavirus program. The activities of the Sr. Scientist must be executed, documented and reported according to Good Clinical Laboratory Practice (GCLP) quality requirements.
The Senior Scientist will be responsible for the scientific quality of the analysis of clinical trial samples, as well as long term life cycle of the methods he/she is the expert on. To that effect, the Senior Scientist needs to consider the long-term strategies of the project and align his plans accordingly. He/ She also needs to understand well regulatory expectations and guidelines, and how this may impact implementation of technical strategies.
For outsourcing activities, the Senior scientist is responsible for making sure the technical/scientific assessment and selection of candidate partners, as well as for monitoring of the scientific quality of the outsourced activities, are performed.
Next being an assay subject matter expert, the senior scientist is also expected to coach and advice other scientists on their projects, and work closely with the Project lead.
The required activities must be executed, documented and reported according to Good Clinical Laboratory Practice (GCLP) quality requirements.Qualifications