Director of Pharmaceutical Development

3 weeks ago


Lévis, Quebec, Canada Groom & Associés Associates Full time

DIRECTEUR (TRICE) DÉVELOPPEMENT PHARMACEUTIQUE SENIOR ET RESPONSABLE DU SITE

Résumé du poste

Relevant du VP Développement Pharmaceutique, le/a titulaire sera responsable d'assurer la réalisation et l'exécution des plans de développements pharmaceutiques en collaboration avec le groupe d'Études Pré-Cliniques pour le portefolio de projets.

Il/elle participera aussi au processus de développement pharmaceutique en collaboration avec les fonctions clinique et réglementaires.

Responsabilités


• Participer, en collaboration avec les groupes Réglementaires et Cliniques, à l'élaboration des plans de développement pharmaceutiques et des méthodes analytiques pour la fabrication de substances médicamenteuses et de produits finis, à l'appui des études pré-cliniques et cliniques.


• Assurer un leadership scientifique, organisationnel et opérationnel pour le développement des produits pharmaceutiques, en encadrant les groupes de Bioproduction et d'Études Pré-Cliniques, afin de rencontrer les exigences techniques, réglementaires et de l'entreprise.


• Développer des procédés et les mettre à l'échelle en respect des exigences réglementaires et des BPFs.


• Définir le plan de développement des activités analytiques, y compris l'élaboration de méthodes analytiques, la validation de méthodes, le transfert de méthodes et l'analyse dans un environnement de R&D et de BPF.


• Planifier et exécuter des études de développement et de caractérisation de procédés à l'échelle du laboratoire et à l'échelle réelle.


• Communiquer l'état d'avancement des projets à la direction ainsi qu'aux collaborateurs ; communiquer toutes situations pouvant avoir un impact sur l'atteinte des objectifs.


• Préparer et approuver des documents techniques, notamment des rapports de recherche, des rapports de développement et des documents relatifs à la fabrication de substances médicamenteuses et de produits finis.


• Collaborer avec d'autres secteurs fonctionnels, notamment les groupes d'Études Pré-Cliniques, Affaires réglementaires et de Qualité afin d'atteindre les objectifs des projets.


• Participer à la préparation des documents relatifs aux spécifications, aux procédures opérationnelles normalisées et à d'autres documents nécessaires pour les opérations relatives aux produits pharmaceutiques.


• Participer au développement et la révision des documents réglementaires requis.


• Participer aux processus d'investigation au besoin.


• Assurer un rôle de personne-ressource auprès de ses collègues dans le cadre de ses fonctions.


• Maximiser les performances de l'équipe sous sa responsabilité.


• Veiller à ce que la sécurité du site et les pratiques de laboratoire généralement acceptées soient mises en œuvre.


• Assurer la gestion des programmes d'entretien et de calibration du site et des équipements.

Exigences


• Minimum baccalauréat en science, un doctorat serait un atout (pharmacie, chimie ou biologie) avec 7+ années d'expérience dans un environnement de développement pharmaceutique similaire.


• Connaissances spécialisées dans le développement de formulations de bioprotéines, de vaccins et de produits biologiques.


• Familiarité avec les techniques de purification de bioprotéines et des techniques analytiques tel que SDS-PAGE, Western Blot, ELISA, etc.


• Expérience de la mise à l'échelle des procédés de fabrication et purifications de bioprotéines.


• Maitrise des exigences BPF (Santé Canada, FDA, EMA) ainsi que des pharmacopées USP et EP.


• Doit être capable de travailler dans un environnement en évolution rapide avec des interruptions fréquentes.


• Capacité à hiérarchiser les tâches et à gérer plusieurs projets du début à la fin avec un minimum de supervision.


• Bonnes compétences de communication verbales et écrites.


• Souci du détail et excellentes compétences organisationnelles.


• Motivé, autonome et enthousiaste, axé sur les résultats.


• Compétences démontrées dans la suite de produits MS Office.

Conditions de travail


• Horaire: 37,5 heures par semaine


• Présence sur site non hybride


• Poste basé à Levis – Québec



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