
Scientist, Process Development
- Alberta
- Permanent
- Full-time
- provide guidance to process chemistry personnel in the evaluation of chemical processes in the laboratory
- provide process safety assessments for active pharmaceutical ingredient (API) manufacturing performed under cGMP including documentation related to batch records and specifications
- Support the development of the process safety evaluation system and procedures for the site
- In collaboration with senior scientists, develop strategies for the safe manufacturing of drug substances to support clinical studies and commercialization
- Demonstrate technical knowledge, scientific creativity, and collaboration skills in the development and execution of process safety assessments for the preparation of novel chemical substances
- Ensure all experimentation is carried out in accordance with appropriate standard operating procedures (SOPs), maintaining quality, safety, and environmental standards
- Support process safety assessments and investigations relating to the manufacturing of drug substances, including:
- use of appropriate methods and techniques (e.g., DSC, ARC, RC1) to support process development activities and other project goals
- interpretation of data and presentation of process hazard evaluation results
- Support the continuous improvement of systems on site with a particular focus on personnel and process safety.
- Maintain alignment with corporate process safety goals, and direct personnel with interpretation of and compliance with process safety requirements
- Support the development, management, and promotion of site process safety programs and systems, including development of process safety assessment tools, training programs, and other tools to support site safety culture and performance
- Doctorate OR
- Master’s and 4+ years of relevant experience OR
- Bachelor’s and 6+ years of relevant experience OR
- planning and executing multi-step synthesis of organic molecules
- scaling up synthetic routes and developing safe processes
- thermal analysis techniques
- understanding of chemical engineering principles
- pharmaceutical/fine chemical industry experience in process safety and development
- Application of sound and scientific judgment to make timely decisions
- Strong collaboration, communication, and writing skills are required