Bilingual Junior Collections Specialist - Canada - Pharmascience Inc.

Description

The incumbent, reporting to the Manager, Technology Transfer


OSD:

Is responsible for the transfer to or between Pharmascience production sites of new pharmaceutical processes/products, mainly, but not limited to oral solid dosage (OSD) 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.

Acts 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.

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 to ensure operational readiness prior to commercial manufacturing.

Is responsible to ensure successful technology transfer according to pre-defined success criteria.
Acts as a technical leader for the team members .
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.
Writes the technology transfer plan.

Supervises the operational team in the production of batches at the end of development, provides technical guidance or troubleshoots problems.

Supports, through his/her technical expertise, the Formulation team in the design and scale-up of the manufacturing process.
Supports the Technical Writing team in the creation/revision of manufacturing documents.
Reviews and approves manufacturing documents written by the Technical Writing team.
Supervises the operational team in the production of submission batches, provides technical guidance and troubleshoots problems.

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. Responsible for the manufacturing of transfer batches and for optimizing the manufacturing process at commercial scale

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.

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 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.

Act as a technical leader for the team members
Contributes to the training of new team members.
Technically guides and supports the team members in the different projects.
Reviews technical documents written by the team members, as needed.
Acts as the back-up of the technicians (Junior Specialist only).
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.
Establishes the equipment train adapted to the different scales included in the technology transfer.
Initiates the technology transfer with collection of all data on the process/product to be transferred.
Bilingual English/French (oral and written)
Excellent GMP knowledge for manufacturing and packaging of solid, semi-solid, liquid, ointments/creams, suppositories
Excellent ability to work on several projects at the same time
Excellent writing skills
Bachelor or better in Engineering or related field.
Bachelor or better in Science or related field.
10 years in pharmaceutical industry, preferable in Production, Technology Transfer or Formulation/Process Development. #