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.

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 conduct of pilot-lab or production-scale trials.
Support the supervisor in the production of feasibility and characterization batches when introducing current 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:
Transfer reports (Evaluation, Critical parameters, Integrity, Filter validation, etc.);
Annual reviews;




Change 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.

REQUIREMENTS AND SKILLS
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 adaptable.
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.

📌 Technology Transfer Specialist Temporary, 12 Months Montreal
🏢 JUNO PHARMA CANADA
📍 Montreal