Specialist, Production Technical Support
3 months ago
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
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