Manager Quality and Technology

1 month ago

Candiac, Canada Pharmascience Full time

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.

Responsibilities & Duties
  • 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 meets 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.
Quality Assurance
  • Maintains 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
  • 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.
  • 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.
  • Autonomous.
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