SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
The companyOur client is a professional Pharmaceutical organization, based in Zuid-Holland Netherlands. The organisation is well-known for operating in Medical Devices and Pharmaceuticals worldwide.
Role descriptionThe Clinical Immunology department is responsible for the immunological evaluation of vaccine candidates in clinical trials. Hereto, the department executes the immunological strategy supporting the clinical development, and ensures the development, and validation of the required immunological assays, as well as the clinical sample analysis. Typical assays to determine the immunogenicity of vaccines are the antibody ELISA, T cell ELISpot, Intracellular Cytokine Staining, and virus neutralization assays.
ResponsibilitiesThe Analytical Project Manager (APM) main responsibility is to ensure the timely and correct sample analysis of clinical samples, either in house or outsourced to CRO’s or partners. For outsourcing, the APM is responsible for the technical and scientific evaluation and selection of candidate partners, and for monitoring the outsourced activities. For in house activities the scientist is responsible for the design, coordination and execution of assay development and validation, and for the organization of the clinical sample analysis. The required activities must be executed, documented and reported according to Good Clinical Laboratory Practice (GCLP) quality requirements.
Requirements• HLO/Master in biological/medical sciences and several publications in immunology (no PhD)
• Minimal 3 years working experience
• Knowledge of immunological assay development and validation
• Experience in clinical development of vaccines
• Communicative skills
• Fluency in English required, Dutch is highly advantaged
• Basic management skills
• Trained in GCLP and/or GLP is a strong plus
• Analytical minded, who enjoys working full time on procedures and guidelines