Specialist, Production Technical Support

2 months ago

Montreal, Canada Pharmascience Inc. Full time
Specialist, Production Technical Support

Job Category: Manufacturing

Requisition Number: SPECI003193

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  • Posted: August 30, 2024
  • Full-Time
  • Hybrid
Locations

Showing 1 location

As the Specialist, Production Technical Support, you will be responsible for identifying and evaluating 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 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)
  • 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 (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:

  • Bachelor's or Master's Degree in Sciences - Biochemistry, Chemistry, Pharmacy, Pharmaceutical Technology and/or Engineering
  • 5 years of experience in a pharmaceutical environment, preferably in manufacturing, technology transfer, formulation, or development of manufacturing processes
  • Good written and oral communication skills (English and French) as the incumbent will have to read and write documentation for suppliers and clients located outside the province of Quebec.
  • Analytical skills
  • Dynamic, self-sufficient
  • Capable of working on many projects simultaneously
  • Excellent knowledge of Windows and MS Office tools (Word, Excel, PowerPoint)
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