Chef, transfert technologique Stérile

The incumbent, reporting to the Senior Manager, Technology Transfer, is :

• Responsible for managing the team in charge of the technology transfer of new pharmaceutical products / processes of sterile forms developed internally by the Formulation Development department or externally by a business partner for the transfer to the Candiac production site of Pharmascience.
• Responsible for maintaining a high level of performance and quality of the transferred pharmaceutical products / processes and for ensuring the success of the technology transfer according to predefined success criteria and within challenging timelines.

Responsabilities & Duties

Responsible for managing the team in charge of the technology transfer of new pharmaceutical products / processes

• Manages the activities of the technology transfer team.
• Contributes to the evaluation of new business opportunities, for internal development projects or CDMO / CMO projects with business partners, to ensure a preliminary assessment of the feasibility of the technology transfer.
• Identifies the gaps associated with the technology transfer and defines remediation strategies.
• Supports, as needed, the purchase of new equipment.
• Contributes with the Formulation Development department to the design of the manufacturing processes based on the formulation.
• Ensures proper scale up of the manufacturing processes, which includes the selection of
• equipment train based on production scale and the determination of appropriate process parameters.
• Manages the technology transfer of new pharmaceutical products / processes up to commercial scale with the collaboration of the Formulation Development department or the business partner.
• Prepares and supports the production plants for the manufacturing of different batches during the development and transfer of new pharmaceutical products / processes.
• Offers technical expertise during the development and technology transfer in the design, investigation, troubleshooting, optimization, improvement of new pharmaceutical products / processes, and provides recommendations.
• Defines action plans in the event of failures during technology transfer.
• Approves technical documents generated by the technology transfer team (e.g. transfer plans and strategies, protocols and reports, deviations).
• Ensures that the technology transfer team meet target dates as per project plan.
• Prepares and supports responses to requests from regulatory authorities regarding the work related to technology transfer, as needed.
• Ensures proper knowledge transfer to Global Operations upon closure of the technology transfer.
• Provides technical expertise to Global Operations, as needed.

Responsible for maintaining a high level of performance and quality of the transferred pharmaceutical products / processes and for ensuring the success of the technology transfer according to predefined success criteria and within challenging timelines

• Does the needful to maintain a high level of performance and quality of pharmaceutical products / processes transferred to commercial scale.
• Ensures that the team's activities meet current regulatory requirements.
• Ensures team adherence to common objectives.
• Coordinates and collaborates with the various cross-functional groups to ensure the success of the technology transfer according to predefined success criteria.

Other general responsibilities and duties

• Evaluates the workload of the technology transfer team associated with new opportunities.
• Monitors the team workload and the available capacity to work on new projects.
• Manages the procedures that govern the activities of the technology transfer team.
• Recruits, manages, motivates and evaluates team personnel.
• Coaches, trains and develops the team.
• Encourages continuous improvement and training within the team and leads initiatives in this direction.
• Ensures collaboration between various departments.
• Maintains a positive and stimulating work environment.
• Participates as a technical expert in several meetings and working groups.
• Approves documents issued by other departments requiring approval by the technology transfer team.

Skills, Knowledge & Abilities

• Bilingualism, as the person will have to collaborate with regulatory authorities located outside the province of Quebec, as well as with suppliers and / or customers located outside the province of Quebec, and finally will have to read and write documentation exclusively in English as part of his / her duties.
• Grande connaissance des équipements et procédés de fabrication pharmaceutique
• Grande compréhension et connaissance des normes de l’industrie
• Excellentes aptitudes en gestion
• Excellentes aptitudes de leadership
• Grand sens de l’organisation et de la collaboration
• Maitrise de l’anglais et du français
• Excellente communication orale et écrite
• Bonnes aptitudes en rédaction technique
• Orientation sur les résultats
• Grande capacité en résolution des problèmes
• Dynamique
• Autonome
• Maitrise de l'environnement Windows et des outils MS Office (Outlook, Word, Excel, Powerpoint, Teams)
8 days ago