Manager Quality and Technology
1 week ago
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.
- 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.
- 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.
- 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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