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Scientist Clinical Immunology
Requisition ID: 1805624935W
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.
For our Clinical Immunology department, we are currently recruiting for a fulltime
Scientist Clinical Immunology
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 laboratory scientist’s main responsibility is to ensure for the proper design and hands on execution of Immunological assay development and validation to support analysis of clinical trials sample. The required activities must be executed, documented and reported according to Good Clinical Laboratory Practice (GCLP) quality requirements and in compliance with International guidelines. Additionally, the lab scientist will be responsible for the scientific quality of sample 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 lab scientist needs to take into account the long term strategies of the project and align his scientific strategy accordingly.
- PhD in biological/medical sciences or equivalent, with strong immunology or virology background
- Solid, hands-on experience of bio-assay development to validation according to regulatory standards (>1 years’ experience in Pharma/ Biotech setting or equivalent) such as ICH
- Previous experience with setting up assays for immunological assessment of mucosal samples with be a plus.
- Experience in clinical development of vaccines or large molecules; late phase trials will be a great advantage.
- Excellent communication skills, fluent in English.
- Experienced in working under quality standards such as GCLP, GCP or GMP.
- Practical experience with Lean and process excellence.
The right candidate is:
Quality minded and flexible.
Able to remain calm and positive under pressure.
A team player with soft skills, able to motivate and empower others.
Good planning and coordinating skills.
“Caring for the world, one person at a time…”
As an employee, we consider you as our most valuable asset. We take your career seriously. As part of a global team in an innovative environment your development is key and our day-to-day responsibility. Through e-university, on the job training, various projects and programs, we ensure your personal growth. Our benefits make sure we care for you and your family now and in the future.
Janssen Vaccines & Prevention BV (8852)