Drug Substance Production Lead

3 weeks ago

Laval, Canada Moderna Full time

**The Role**:
Moderna is on the lookout for a dynamic, motivated and dedicated professional to serve as the Drug Substance Production Lead at our new manufacturing site in Canada. You will have a front-row seat as we build and operationalize this state-of-the art mRNA drug substance manufacturing facility, with responsibility for leading the end-to-end operations under the supervision of the Site Head.

You will be responsible for developing, implementing, and supporting manufacturing business systems and commercial production activities. You’ll bring your expertise in bioprocess unit operations and cGMPs to ensure technical success, with a strong emphasis on Operational Safety and adherence to a Quality System that aligns with country and global regulatory expectations.

**Here’s What You’ll Do**:
**In addition, you will**:
Lead a team of Supervisors/Team Leads and Technical Specialists, including third-party service providers to safely produce RNA-based medicines to support commercial manufacturing of vaccines (Covid, Flu, RSV).

Optimize plans and resources (people, facilities, supplies etc.) for efficient manufacturing and timely delivery.

Actively participate in recruitment, training, development, retention, and performance management of staff for effective manufacturing operations.

Provide on-the-floor coaching of the manufacturing and support teams on process execution within a GMP environment.

Ensure the development and maintenance of batch records, SOPs, and training materials for the DNA processes.

Maintain the work centre in a constant state of inspection readiness. Support on-site inspection activity as required.

Collaborate closely with QA peers for rapid batch disposition, including ensuring timely batch record, protocol, and log reviews, deviation investigation support, etc.

Be an efficient matrix contributor and collaborate effectively in cross-functional local and global settings with MST, Ops, SC, etc.

Drive operational readiness for new product introductions and technology transfers.

Develop comprehensive operating plans in collaboration with cross-functional peers and monitor the achievement of business and financial goals.

Manage multiple projects alongside operations in a fast-paced environment.

Foster a culture of continuous improvement leveraging Lean and Six Sigma principles.

Role model Moderna’s culture and foster an exciting dynamic work environment for the team.

**Here’s What You’ll Bring to the Table**:
We are looking for someone with a strong background in Operational Excellence to establish a robust foundation of Tier systems, Lean, and Six Sigma principles throughout the facility startup and ramp up phase.

**In addition**:
A university degree in engineering or sciences and 12 or more years of experience in all manufacturing processes in a pharmaceutical or biotechnology environment.

Proven senior plant management experience and a strong background in implementing Tier (Lean) principles.

Strong quality mindset, with deep understanding of cGMP guidelines and regulations.

Excellent communication and presentation skills. Proficiency in English required.

Proficiency in conflict resolution and crucial conversations.

Technical writing skills and proficiency in investigations and root cause analysis.

Proven ability to assess risk, collaborate with support groups to develop suitable action plans, and minimize potential impact.

Strong role-modelling of Moderna Mindsets

A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

Le rôle
Moderna est à la recherche d'un professionnel dynamique, motivé et dévoué pour occuper le poste de Responsable de la Production de Substances Médicamenteuses dans notre nouveau site de fabrication au Canada. Vous aurez un rôle privilégié à jouer lors de la construction et de l’opérationnalisation de ces installations de fabrication de substances médicamenteuses à base d'ARN messager. Vous dirigerez les opérations de bout en bout, sous la supervision du Responsable du Site.
Vous serez responsable du développement, de la mise en œuvre et du soutien des systèmes d'exploitation et des activités de production commerciale. Vous apporterez votre expertise dans les opérations unitaires de bioprocédés et les bonnes pratiques de fabrication (BPF) pour assurer le succès technique, en mettant fortement l'accent sur la sécurité opérationnelle et le respect d'un système qualité conforme aux attentes réglementaires nationales et mondiales.

Voici ce que vous ferez

Diriger une équipe de superviseurs/chefs d'équipe et de spécialistes techniques, incluant des prestataires de services, pour produire en toute sécurité des médicaments à base d'ARN afin de soutenir la fabrication commerciale de vaccins (Covid, grippe, VRS).

Optimiser les plans et les ressources (personnel, installations, fournitures, etc.) pour une fabrication efficace et une livra

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