Specialist, Production Technical Support

at  Pharmascience Inc

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.

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.
• Good writing skills
• Analytical skills
• Excellent organization skills
• Dynamic, self-sufficient
• Capable of working on many projects simultaneously
• Excellent knowledge of Windows and MS Office tools (Word, Excel, PowerPoint)

EXPERIENCE

Required

• 5 year(s): Experience in a pharmaceutical environment, preferably in manufacturing, technology transfer, formulation, or development of manufacturing processes

EDUCATION

Preferred

• Bachelor or better in Génie chimique - Chemical Engineering or related field
• Bachelor or better in Production pharmaceutique - Pharmaceutical Ma or related field
• Bachelor or better in Pharmacie - Pharmacy or related field
• Bachelor or better in Chimie - Chemistry or related field
• Bachelor or better in Biochimie - Biochemistry or related field
• Bachelor or better in Science or related field

• 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 (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.