- Type Contract
- Salary Negotiable
- Location Leiden, South Holland
- Sectors R&D
Hours per week: 40
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 Vaccines with services in Scientific and operational excellence, with high standards of quality and compliance.
The main responsibility of the Laboratory Scientist is 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. His/her activities must be executed, documented and reported according to Good Clinical Laboratory Practice (GCLP) quality requirements.
The laboratory scientist is responsible for performing experiments on a regular basis to support assay development processes, but also to maintain his/her technical edge, and to remain aware of the issues and potential areas of improvement in the laboratory. He is responsible for instructing associate and assistant scientist on the scientific fundamentals of the assays which are used in the lab, and to review to the data generated by them.
Besides, the Laboratory Scientist is 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 Laboratory Scientist needs to consider 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
* 2-3 years of experience in a pharmaceutical, biotech company
* Affinity for data analysis and the thorough review of the data generated by others
* Extensive, hands-on experience in the development to validation of serology (ELISA,VNA or other) or cell-based assays (ELISPOT, flow cytometry assays or other) according to regulatory standards .
* Recent experience in optimizing serology or cell-based assays is a plus
* Recent experience in optimizing isolation, freezing and thawing of PBMCs is a plus
* Knowledge of procedures to establish comparability and bridging of critical reagents is a plus
* Knowledge of biostatistics is a plus.
* Experience with experimental plans using the "Design of Experiment (DoE)" principles is a plus
* Excellent communication skills, fluent in English.
* Experienced in working under quality standards such as GCLP, GCP or GMP.
Are you the new Laboratory Scientist? Apply now online or to speak to Michelle Smit via 020 522 15 88 or m.smit[a]realstaffing.com