INGÉNIEUR EN CYTOMÉTRIE EN FLUX - analyses précliniques et cliniques
On site
Thuin, Belgium
Full Time
16-04-2025
Job Specifications
Dans le cadre de la croissance de son activité et en vue d’un important agrandissement de ses laboratoires, Quality Assistance souhaite engager un.e Ingénieur.e en Cytométrie en flux pour son équipe bioanalyse qui travaille sur des projets clients dans le cadre d’études précliniques et cliniques.
Vous rapporterez au Responsable de l’équipe Immunoassay.
Vous ferez partie d’une équipe de 5 à 6 personnes.
L'équipe que vous intégrerez offre un service d'analyse d'échantillons biologiques (sang, plasma, sérum, tissus, urine, etc.) par immunoessai et cytométrie en flux dans le respect des guidances internationales (GLP, GCP, GCLP, EMA, FDA, ICH) pour des tests de dosages pharmacocinétiques, dosages ADA (anti-drug antibodies), dosages de biomarqueurs, etc.
Après une période de formation et d’intégration et en collaboration avec le Team Leader :
Vous participerez au traitement et à la préparation des échantillons reçus afin d’effectuer des dosages et analyses en appliquant les protocoles d’étude en vigueur
Vous appliquerez les méthodes existantes
Vous assurerez, en autonomie, le transfert ou le développement de nouvelles méthodes analytiques
Vous assurerez, en autonomie, la validation des méthodes analytiques dans le respect des guidances
Vous traiterez les données, interpréterez les résultats, les discuterez et en tirerez des conclusions
Vous validerez les raw data
Vous rédigerez des protocoles et des rapports d’étude
Vous participerez à la vie du laboratoire : maintenance d’un appareil spécifique selon les procédures, suivi des réactifs, amélioration continue, etc.
En fonction de votre niveau d'expertise et d'autonomie, vous pourrez également :
Fournir du support lors d'audits et/ou d'investigations
Écrire et/ou réviser les protocoles et procédures pour l'équipe après échanges avec les managers
Participer à la formation interne du personnel sous la supervision des managers
Votre profil
Background scientifique
Les requis :
Minimum trois années d’expérience dans un poste similaire dans un cadre BPL
Bonne expertise technique en Cytométrie en flux appliquée à l’analyse d’échantillons précliniques et/ou cliniques
Expérience en validation de méthodes pour des études précliniques et cliniques
Bonne connaissance des guidances (EMA, FDA, ICH) applicables à la bioanalyse
Bonnes connaissances en immunologie
Bonne capacité à s’exprimer en français et/ou en anglais (rédaction de rapports/documents scientifiques, rédaction d’e-mails, contacts avec les clients, etc.)
Bon esprit d’équipe
Multitâche, vous êtes capable de prioriser votre travail et de travailler en autonomie
Rigoureux, vous parvenez à identifier les anomalies/problèmes/difficultés rencontrés lors de la réalisation des analyses
Les plus :
Bonne connaissance pratique et théorique des techniques suivantes : Immunoessai (ELISA, ECLIA et/ou Gyrolab) pour dosage PK et/ou ADA, Multiplex, Cell-based assays
Connaissance des produits biothérapeutiques (anticorps monoclonaux, anticorps conjugués, protéines, peptides recombinants) et des règlementations en vigueur dans ce domaine (EMA et FDA).
About the Company
Quality Assistance S.A. is a leading European Contract Research Organisation (CRO) providing the pharmaceutical industry with all the analytical services required by EMA and FDA regulations for the development and marketing of innovative human medicinal products. We assist our clients through non-clinical and clinical studies to marketing authorisation, using our state-of-the-art, product-dedicated expertise in analytical sciences. For each client project, we design customised solutions, define analytical protocols, develo... Know more
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