Specialist, Production Technical Support

As the Specialist, Production Technical Support, you will be responsible to identify and evaluate the manufacturing processes of products already marketed (Internal and / or external) to improve their quality, costs and / or efficiency. You will evaluate new sources of raw materials and / or excipients and make recommendations. You will perform the various tasks related to process improvement and site change.

Tasks and Responsibilities :

• Participate in supplier selection (CMO) Generate equipment listAssess and develop process to be transferredPrepare technical comparisonEstimate risk vs choice of supplier based on the equipment selected and the manufacturing process
• Participate in preparation of Business Case Evaluate cost and time needed for technology transfer
• Suggest batch sizes (feasibility and commercial batches) based on equipment available from the supplier
• Participate in creating / reviewing manufacturing sheets (feasibility and commercial) Support technical writers (CMO) in creating / reviewing feasibility batch manufacturing sheetsReview feasibility batch manufacturing sheets prepared by the technical writers (at CMO)Together with technical writers (at CMO), develop / review the commercial manufacturing sheets.Review commercial manufacturing sheets prepared by technical writers (CMO)
• Approve punch drawings
• Responsible for manufacturing transfer batches and for optimizing the manufacturing process during the commercial manufacturing phase. Supervise manufacturing of the first commercial batches (transfer and validation batches) and prepare follow-up reports.Investigate and prepare action plans in case problems arise during manufacturing or following out-of-specs analytical results, together with Production, QA, Validation and other sectors, as needed.Improve the manufacturing process where neededPrepare required GMP documents and implement recommended improvement changes (where needed)Following manufacturing of the first commercial batches, submit improvement recommendations based on the observations and data gathered during the technology transfer.Write final technology transfer reports following manufacturing of the first commercial batches.Write “side by side” in preparation for change control report.Support technical writers in reviewing commercial manufacturing sheets in accordance with improvement recommendations and validated metrics. Participate in several meetings related to the technology transfer.Provide support in answering several groups’ questions (i.e. Project Manager, Validation, QA, Production, Analytics, Regulatory Affairs, etc.)
• Responsible for evaluating the manufacturing processes of products already marketed to improve their quality, cost and / or efficiency. Responsible for the evaluation of the proposed new sources of raw materials and / or excipients.
• Participates in the development of the Business case Evaluates the cost and time of the tasks to be performed for process improvement, source change.
• Develops the process improvement strategy Collects the required documentation to revise the existing manufacturing process (history, investigation, development Report, etc.) Discusses problems and possible improvements with the various departments (production, formulation, technology transfer Group, analytical group etc...)
• Responsible for manufacturing and packaging of process improvement trial batches, feasibility batches for source changes : Reserves the raw materials, excipients and packaging componentsReserves resources (human and equipment)Sample (if necessary) source change raw materials and send for analysis.Prepares documentation required for batch manufacturing and placeboAssists the operators of the pilot or commercial plant in the production of the trial batches or manufactures the trial batches using the equipment from formulation group.Performs physical tests on raw materials and mixtures of powders (density, flow, determination of particle sizes etc...)Prepares queries for analytical tests and sends samples to analytical groupsWrites process Improvement and source changes reports.Write the "side by side" for the preparation of the change control.
• Participates in the creation / revision of the manufacturing masters (pilot, Engineering and commercial) Supports the technical writers in the creation / revision of the production masters of the pilot & engineering batchesRevises the production masters of the pilot & engineering batches written by the technical writers.Develops / revises in collaboration with the technical writers the commercial manufacturing masters.Revises the commercial production masters written by the technical writers.
• Responsible for the manufacturing of process improvement and source change batches during the manufacturing phase of engineering and commercial lots : Supervises the manufacture of the first engineering and commercial batches (validation batches) and issues follow-up reports (daily reports).Investigates and establishes action plans in the event of problems encountered during manufacturing or following analytical results out of specification in collaboration with Production, QA and other sectors, if applicable.Prepares the required GMP documents to make recommended improvement changes.Issue, following the manufacture of the first engineering and commercial batches, recommendations of improvement based on the observations and the data collected during the manufacturing.Supports technical writers in the revision of the engineering and commercial manufacturing masters according to the recommendations of improvement and according to the validated parameters.

Skills, Knowledge & Abilities :