This job is currently Archived,
Posted on : 09 April 2017
Quality Assistance works on innovative medicinal products under development (preclinical and clinical phases). The projects are on the development, validation and/or application of analytical methods for the study of small and large molecules in biological matrices by Immunoassays and Bioassays. Working in a team involved in projects outsourced by our clients, you will: Independently develop, validate and apply analytical methods, based on a protocol. Process data and write reports and associated supporting documents. Manage GLP and GCLP studies and assist the Team Manager in his daily management. For the projects assigned to you, you will supervise the personnel involved; do the technical follow-up of analyses (troubleshooting); ensure protocols and contracts are respected, communicate internally and with clients; validate experimental results and ensure protocols are respected; write and/or verify reports; manage documentation related to the analyses done; assist the Team Manager in the preparation of practical work and the writing of protocols (development, qualification, validation and transfer). The analytical techniques used are immunoassays and bioassays. Depending on your skills and ambitions, progression in the job is possible. Education Master / Engineer (or PhD), specialisation Biology or Biochemistry. Skills Technical skills Required Thorough theoretical knowledge and practical experience in immunochemistry (Elisa, MSD, Luminex,..) applied to PK, Immunogenicity and Biomarkers studies. General skills Required Very good knowledge of GLP/GCLP quality norms. Good knowledge of biological medicinal products (mAbs, ADCs, proteins, recombinant peptides) and regulations associated (EMA and FDA). Pluses Good knowledge of the pharmaceutical sector. Language skills In addition to proficiency in French, good command of English. Experience Required At least 2 years’ practical experience in pharmaceutical sector in development, validation and application of analytical methods in aforementioned techniques. Pluses A first experience as Study Director. In addition to the fringe benefits received by all the personnel, you will also be provided with a company car.
6536 Thuin Hainaut Belgium
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