1. JOB OBJECTIVES

• Participate in the development of new products while respecting the department's deadlines.
• Develop the work plan for products under development.
• Write documents related to the development of a new product for submission to regulatory agencies and for the transfer of projects from the R&D to commercial phase.

2. PRIMARY FUNCTIONS

Coordinate activities related to the development of new products
• Participate in the evaluation process of new raw materials in collaboration with the API specialist.
• Define the development plan for a product under development and communicate the plan to the appropriate work teams.
• Write product specifications (API, excipients, finished products etc.).
• Address the issues of projects in development and relay information to the teams concerned.
• Review the laboratory protocols proposed by the formulation specialist.
• Write stability protocols for lab batches or pilots of development projects
• Verify the conformity of the data collected according to the regulations in place.
• Coordinate and communicate with the various departments to ensure the proper monitoring and progress of projects according to deadlines.
• Participate in multidisciplinary meetings related to R&D projects.
• Write pharmaceutical development reports that are integrated into regulatory submissions and necessary for the transfer of a project from the R&D to technology transfer phase.
• Participates in the drafting of responses to questions from regulatory authorities by communicating recommendations internally.

Other

• Be on the lookout for new national and international guidelines, regulatory standards and ensure that projects meet them.
• Attend and interact at the various meetings of the department.
• Ensure that deadlines are met and notify your supervisor of any changes made.
• Ensure compliance with SOPs, hygiene rules and occupational health and safety standards.
• Maintain up-to-date reading of procedures and training.
• Perform any other related tasks deemed relevant to this position.

3. ACADEMIC TRAINING

• Bachelor of Science, Pharmacy or any related field.

4. EXPERIENCE REQUIREMENT AND APTITUDES

• Good knowledge of international Good Manufacturing Practices (GMP) regulations.
• Knowledge of chemistry, various pharmacopoeias, development and manufacturing of pharmaceutical products.
• Bilingualism (French/English) and excellent oral and written communication skills.
• Knowledge of computer tools, including the Microsoft suite (Word, Excel, and PowerPoint).
• Attention to detail and good writing skills (draft documents with scientific or technical content).
• Ability to complete several projects simultaneously.
• Analytical reasoning, synthetic mind and organizational skills.
• Autonomy, diplomacy and tact.
• Good listening and problem solving skills.
• Team spirit and good interpersonal skills.
• Ability to work under pressure with tight deadlines and frequent priority changes, while meeting deadlines.