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 list - Assess and develop process to be transferred - Prepare technical comparison - Estimate 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 sheets - Review 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 needed - Prepare 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 components - Reserves resources (human and equipment) - Sample (if necessary) source change raw materials and send for analysis. - Prepares documentation required for batch manufacturing and placebo - Assists 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 groups - Writes 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 batches - Revises 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