- Job type Contract
- Salary competitive
- Location Leiden, South Holland
- Sector Pharma & Biotech
Currently I am looking for a Laboratory Scientist for a pharmaceutical company in Leiden.
Title: Laboratory Scientist
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 main responsibility of the Laboratory Scientist is to guarantee the quality and robustness of the immunological assays to be used for the analysis of samples in clinical trials. The Laboratory Scientist is also 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. His/her activities must be executed, documented and reported according to Good Clinical Laboratory Practice (GCLP) quality requirements.
In specific, the laboratory scientist is responsible for designing, supervising, reviewing and documenting the experiments for assay development and validation. He is responsible for the critical reagents in an assay, the experimental controls to guarantee assay performance, and for training operators on the scientific fundamentals of the assays which are used in the lab. A laboratory scientist is quality-driven, he or she maintains his/her technical edge, and remains aware of the issues and potential areas of improvement in the laboratory
* PhD in biological/medical sciences or equivalent, with strong immunology or virology background
* At least 3 years of experience in a pharmaceutical, biotech company
* 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 functional assays for antibodies (antibody-dependent cell cytotoxicity, or antibody-dependent cell phagocytosis) is a plus
* Recent experience in optimizing isolation, freezing and thawing of PBMCs is a plus
* Affinity for data analysis and the thorough review of the data generated by others
* 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.
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.
Are you the new Scientist? Apply online or to speak to a consultant about this project, contact Niek van Alfen via +31 (0)20 522 1588 or n.vanalfen[at]realstaffing.com