Responsible for the scale-up and transfer of products between the R & D phase and the commercial phase:
- R & D manufacturing (feasibility study, scaled study, engineering batches), regulatory submission batches or clinical and validation batches or commercial launch:
- Assists, through its technical expertise, the formulation team in the definition of the manufacturing process and the criticality of manufacturing parameters.
- Creates / reviews Bill of Material (BoM) for each study or product to be manufactured.
- Define the equipment train and, if necessary, initiate and manage change controls
- Draft risk analysis of the process
- Identifies and approves the purchase of new manufacturing items (tubing, filters, spare parts, etc.) required for the manufacture of these batches.
- Drafts protocols and reports of feasibility or capability studies
- Supports technical writers in creation / revision of production sheets
- Revises production schedules prepared by technical writers
- In support of the Production Group, oversees the manufacture of lots
- Coordinates and writes lessons learned reports
- Issues recommendations for the optimization of the manufacturing process in collaboration with the Formulation team to manufacture batch lots, validation batches and commercial launch.
- Coordinates the investigation and follow-up of action plans in the event of problems encountered during manufacturing or following unusual analytical results in collaboration with Formulation, Production, QA and other sectors, where applicable.
- Drafts technology transfer reports following the manufacture of submission, validation or first commercial launch batches.
- Supports the process validation specialist in the drafting of process validation protocols
- Prepare TT responses to Regulatory Authorities when applying (eg. Clarifax, NON, ...).
- Supports different groups (eg. Formulation, Master Group, Validation, QA, Production & Regulatory Affairs) in the responses to the Regulatory Authorities
- Ensures follow-up of technology transfer activities to project managers
- If necessary, draft procedures related to TT
- Participates in continuous improvement and problem solving activities in Production and R&D
- Other related tasks:
Education and Training :
University level, Bachelor or Master degree in Science and/or Engineering
Minimum 5 years in a pharmaceutical environment, preferably in production, technology transfer, formulation or development of manufacturing processes
Experience in development/characterization of aseptic fill/finish unit operations (freeze/thaw, mixing, lyophilization, sterile filtration, filling, stoppering, visual inspection, etc.) to define critical process parameter
Skills, Knowledge and Abilities :
Excellent sense of organization and of cooperation, brings people together
Excellent spoken and written communication
Knowledge of current standards
Fluent in French and English
Ability to solve problems