The process development specialist role is to support the development, technology transfer and scale-up to GMP facilities manufacturing processes of biotherapeutics molecules. The incumbent will also be involved in process optimization/improvements activities. The position is based out of Montréal, QC.
Duties and Responsibilities
- Perform downstream processing development activities and optimization of manufacturing processes including formulation. Assist if required in the development/optimization of upstream manufacturing processes, including cell line development.
- Participate to the technology transfer and scale-up to contract manufacturing organization, may act as a person in the plant
- Review manufacturing documentation
- Provide technical support during process development and manufacturing activities.
- Participate to process improvements projects (e.g. process robustness, control and cost of good (COGs)).
- Assist in the design and execution of experimental plans to understand the process and its robustness (Identification and characterization of Critical Process Parameters and of Critical Quality Attributes).
- Perform process characterizations studies (e.g. viral clearance studies, resin reuse, process limit evaluations).
- Prepare investigation reports on deviations from the GMP manufacturing process
- Set-up and execute process development experiments as required
- Responsible for experimental data analysis and documentation.
- Keep abreast of current development and process technology trends in the field
- Bachelor (B.Sc.) in pure or applied sciences or equivalent: Minimum 5 years of relevant experience in the biopharmaceutical industry
- Hands-on experience with proteins, particularly process purification via chromatography, filtration-based methods and formulation. Knowledge of using equipment such as AKTA chromatography purification systems, automated tangential flow filtration systems, and normal flow filtration techniques including viral filtration. Experience with mammalian bioreactors and cell processing technologies is also a plus.
- Knowledge of Good Manufacturing Practices in a regulated environment (pharmaceutical) is a plus
- Knowledge of upstream and downstream processes technologies
- Ability to work in cross-functional teams and in a fast-paced environment
- Experienced in problem solving and trouble-shooting
- Excellent verbal and written communication skills
How to Apply
Please submit your CV and cover letter in PDF format to email@example.com. Please indicate the position title in the subject line of your email. We will contact you should we wish to arrange a meeting to discuss this position further.