Spécialiste , transfert technologique

Reporting to the Manager, Technology Transfer Sterile, the Specialist, Technology Transfer is responsible for the transfer to the Candiac Pharmascience production site of new pharmaceutical processes/products of sterile forms developed internally by the Formulation team or externally by a business partner, ensuring the maintenance of a high level of performance and quality up to commercial scale. The person will act as a project leader for the transfer of new processes/products on assigned projects, contributes to the process design, investigation, troubleshooting, optimization, improvement, and provides recommendations. The Specialist Technology Transfer executes different tasks related to technology transfer, particularly to provide technical support and guidance during the execution of the different batches throughout the technology transfer and ensure operational readiness prior to commercial manufacturing and is responsible to ensure successful technology transfer according to pre-defined success criteria.

Responsibilities:

Responsible for the initiation of the technology transfer

Initiates the technology transfer with collection of all data on the process/product to be transferred. Establishes the equipment train adapted to the different scales included in the technology transfer. Assesses the gaps and defines remediation strategies. Writes the technology transfer plan.

Responsible to establish the equipment train and appropriate process parameters specific to the development scale(s) and contribute to the optimization of the manufacturing process during the development phase

Reviews and approves manufacturing documents submitted by Formulation team. Supervises the operational team in the production of batches at the end of development, provides technical guidance or troubleshoots problems. Issues daily reports during batch execution. Supports, through his/her technical expertise, the Formulation team in the design and scale-up of the manufacturing process. Issues recommendations for the optimization of the manufacturing process, in collaboration with the Formulation team, up to submission scale. Approves punch design drawings.

Contribute to the creation/revision of manufacturing documents for submission/clinical batches

Supports the Technical Writing team in the creation/revision of manufacturing documents. Reviews and approves manufacturing documents written by the Technical Writing team.

Responsible to establish the equipment train and appropriate process parameters specific to the submission scale and contribute to the optimization of the manufacturing process during the submission phase

Writes the evaluation protocols, and the deviations to the protocols as needed. Supervises the operational team in the production of submission batches, provides technical guidance and troubleshoots problems. Issues daily reports during batch execution. Issues recommendations for the optimization of the manufacturing process, in collaboration with the Formulation team, for the transfer to commercial scale. Performs data compilation and analysis, and drafts reports.

Contribute to the creation/revision of the manufacturing documents for the commercial scale.

Develops and reviews, in collaboration with the Technical Writing team, the manufacturing documents at commercial scale. Reviews and approves manufacturing documents at commercial scale written by the Technical Writing team.

Responsible to establish the equipment train and appropriate process parameters specific to the commercial scale and responsible for the manufacturing of transfer batches and for optimizing the manufacturing process at commercial scale

Defines the engineering strategy. Writes the engineering protocols, and the deviations to protocols as needed. Prepares, when needed, a parallel comparison (side by side) between sending unit and receiving unit or between scales with rationale. Supervises the operational team in the production of first commercial scale batches, provides technical guidance and troubleshoots problems. Issues daily reports during batch execution. Investigates and establishes action plans in case of problems encountered during manufacturing or after out of specification analytical results in collaboration with Formulation, Production, Quality Assurance and other departments. Performs process improvement where needed. Prepares the required GMP documents to make the recommended improvement changes. Performs data compilation and analysis, and drafts reports.

Responsible for the closure of the technology transfer

Issues, following the production of the first commercial scale batches, recommendations, lessons learned, based on the observations and data collected during the technology transfer to ensure proper knowledge transfer to Global Operations. Concludes on overall technology transfer activities following the successful execution of the commercial validation batches, and drafts the final technology transfer reports. Prepares and shares with Global Operations the closure package.

Responsible for multiple other assigned tasks

Contributes as an SME in various meetings related to the technology transfer. Completes all documentation related to the assigned projects, and support for other projects when needed. Drafts responses to questions of the Regulatory Authorities following new product submission. Gives support in activities related to the technology transfer to several groups (e.g. Formulation, Validation, Quality Assurance, Production & Regulatory Affairs). Drafts, if necessary, the procedures related to the technology transfer.

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