1. JOB OBJECTIVES

The specialist assists the Technology Transfer Supervisor in providing technical support for technology transfer activities. He/she works with a team of specialists (production, quality assurance, quality control, validation, engineering, etc.) to support production batches and/or external customers' batches regarding our operations. These activities include assistance in writing and reviewing manufacturing and packaging records.

2. PRIMARY FUNCTIONS

• Support the Supervisor during technology transfer activities, including manufacturing and packaging of batches from internal or external customers;
• Assist in the drafting of production and packaging records;
• Participate in the optimization and/or adaptation of manufacturing processes during technology transfers, including the manufacturing of pilot-lab or production-scale trials;
• Support the Supervisor in the production of feasibility and characterization batches when introducing new products into production, in partnership with the various groups involved;
• Support production and assess impact when determining/changing pilot and commercial batch sizes;
• Participation/support for the writing of:

oTransfer reports (Evaluation, Critical parameters, Integrity, Filter validation, etc.);

oAnnual reviews;

oChange controls;

• Carry out and document investigations in partnership with the groups involved;
• Contribute to problem-solving during technology transfer activities; Provide monthly reports (KPIs);
• Perform any other related tasks deemed relevant to the position.

3. EXPERIENCE REQUIREMENT AND APTITUDES

• Bachelor's degree in chemistry, chemical engineering or related field;
• 3 to 5 years' experience in manufacturing, formulation, process development and analytical laboratory;
• Hands-on experience with the operation of pharmaceutical production equipment (weighing, mixing, bagging, blistering and filling);
• Experience in writing change controls, protocols and reports, and implementing related action plans;
• Experience in creating and approving manufacturing and packaging records;
• Bilingualism (French, English), both oral and written;
• Organized, meticulous, observant, able to work under pressure and as part of a team;
• Customer-oriented and flexible;
• Knowledge of current pharmaceutical standards (GMP's, FDA and DGPSA);
• Knowledge of USP/EP/BP/JP pharmacopeias;
• Knowledge of regulatory requirements (FDA, Health Canada) relating to files.