Quality Assurance – Project Manager
One of the biggest innovative healthcare companies in the world compromised to ally technology with knowledge providing always the best quality service in the past 130 years, the most known areas from this company are pharmaceuticals, medical devices, and consumer health.
The Clinical Immunology department is responsible for the immunological evaluation of vaccine candidates in clinical trials. Hereto, the department delivers data, which defines the immunological strategy supporting the clinical development. This includes next to clinical sample analysis, development and validation of the required immunological assays. Typical assays to determine the immunogenicity of vaccines are the antibody ELISA, Virus Neutralization Assays, T cell ELISpot, and Intracellular Cytokine Staining.
As assistant scientist you will report to the Operations team lead for training and job performance. You will perform the serological immuno-assays (ELISA, Virus Neutralization Assay) needed to deliver the immunological data for clinical studies and support the development of assays needed for clinical sample analysis. The activities will be performed in a GCLP accredited lab, meaning that all activities must follow prescribed procedures, and must be documented accurately in (digital) lab note books. For every finished experiment you will report the data to the scientist, who does the scientific review of the experiments. In case of development, you will discuss the outcome and plan for follow up experiments.
- MLO/HLO or BSc in a relevant field.
- Must have experience working (internship acceptable) in GLP, GCLP, GMP, CCKL (or other lab related quality system, focusing on traceability) regulated environment
- Affinity with automated systems such as LIMS-
- Experience with pipetting robots such as TECAN is a plus
Are you ready to a new step in your career? Feel free to contact me.