Drug Substance Ms&t Lead

7 months ago

Laval, Canada Moderna Full time

**The Role**:
This is a newly created role in the New Manufacturing and Expansions department to support Moderna’s new site startup and continue manufacturing activities. Based in Lava, Canada; this role will lead a group of 2 to 5 scientists and engineers responsible for technology transfer, process start-up, drug substance manufacturing process validations, and commercial cGMP manufacturing support.

The Site Drug Substance MST Lead will lead a team responsible for technical support of Moderna cGMP manufacturing activities at the new facility in Laval, Canada. Working alongside Moderna’s manufacturing operations and QA teams, the MST Lead will lead collaborative teams that establish and sustain Moderna’s cGMP manufacturing processes.

**Here’s What You’ll Do**:
Ensure successful technology transfer of Moderna processes into manufacturing operations. Manage and document process and project information with a robust documentation package.

Be the point of contact for manufacturing issues requiring technical investigations. Identify root cause. Coordinate and resolve issues with effective CAPAs

Ensure successful validation of Moderna manufacturing processes at the respective site.

Manage change as part of a Global Change Control forum

Maintain alignment with other global manufacturing sites through shared knowledge, shared manufacturing data, shared manufacturing issues, and common solutions.

Lead a diverse group of scientists and engineers by establishing common practices, establishing a data-driven culture, using metrics for improvements, and being hands on in risk assessment and defining solutions.

Actively participate in health authorities' audits

**Here’s What You’ll Bring to the Table**:
M.S. or Ph.D. in a technical discipline related to Pharmaceutical Manufacturing (Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Engineering, etc.)

A minimum of 10 years of related work experience

Prior managerial experience. Ability to mentor staff in technical areas outside your area of expertise

Direct experience providing technical support of cGMP manufacturing operations in biologics manufacturing or parenteral drug product manufacturing. Experience includes technology transfer, investigations, and change management.

Experience using statistical process control and process analytics for monitoring and improving control of processes.

Demonstrated capability of working cross-functionally in a technical area outside of core expertise.

Experience supporting commercial cGMP manufacturing processes preferred.

**Le rôle**:
Ce poste a été créé au sein du département de la fabrication et des expansions pour soutenir le démarrage du nouveau site de Moderna et poursuivre les activités de fabrication. Basé à Laval, Canada, ce rôle dirigera un groupe de 2 à 5 scientifiques et ingénieurs responsables du transfert de technologie, du démarrage des processus, de la validation des processus de fabrication de substances médicamenteuses et du soutien à la fabrication commerciale conforme aux BPF.
Le responsable MST (Manufacturing Science and Technology) pour la substance médicamenteuse dirigera une équipe chargée du soutien technique des activités de fabrication conformément aux BPF de Moderna sur le nouveau site de Laval, Canada.

**Voici ce que vous ferez**:
Assurer le transfert des processus de Moderna vers les opérations de fabrication. Gérer et documenter les informations sur les processus et les projets avec un ensemble de documentation solide.

Être le point de contact pour les problèmes de fabrication nécessitant des enquêtes techniques. Identifier la cause. Coordonner et résoudre les problèmes avec des CAPA efficaces.

Assurer la validation des processus de fabrication de Moderna sur le site en question.

Gérer les changements dans le cadre d'un forum mondial de contrôle des changements.

Maintenir l'alignement avec les autres sites de fabrication mondiaux grâce au partage de connaissances, de données de fabrication, et de solutions communes.

Diriger un groupe diversifié de scientifiques et d'ingénieurs en établissant des pratiques communes, en instaurant une culture axée sur les données, en utilisant des indicateurs d’amélioration et en étant impliqué dans l'évaluation des risques et la définition des solutions.

Participer activement aux audits des autorités sanitaires.

**Voici ce que vous apporterez (Qualifications requises)**:
M.S. ou Ph.D. dans une discipline technique liée à la fabrication pharmaceutique (chimie, biochimie, génie chimique, génie pharmaceutique, etc.).

Un minimum de 10 ans d'expérience professionnelle en lien avec le domaine

Expérience antérieure en gestion d’équipe. Capacité à encadrer le personnel dans des domaines techniques en dehors de votre domaine d'expertise.

Expérience directe dans le soutien technique des opérations de fabrication conforme aux BPF dans la fabrication de produits biologique

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