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Chef, transfert technologique Stérile

Chef, transfert technologique Stérile

PharmascienceCandiac, CA
12 days ago
Job type
  • Full-time
Job description

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)