The role of the research associate is to participate in the development of manufacturing processes for the expression and/or purification of therapeutic recombinant proteins. Processes are developed as part of scaling up and manufacturing according to Good Manufacturing Practices (GMP). Another important part of this role is the rapid production of recombinant proteins using the company’s laboratory platform for the selection of candidate proteins. The incumbent will use defined scientific practices to develop and/or use protein production procedures to support technology transfer to contract manufacturing organizations. Other responsibilities include participating in the maintenance of laboratory equipment and the evaluation of data trends.
This is a full-time position reporting to the Associate Director of Process Development and is based in Montreal, QC, Canada.
Functions and responsibilities:
- Produce recombinant candidate proteins from the CHO/HEK-293 cell line system platform using shaker flasks, bioreactors (WAVE), clarification, filtration, chromatography (e.g.: affinity, ion exchange, hydrophobic interaction) and formulation (tangential flow filtration) techniques, among others.
- Perform mammalian cell culture activities such as cell maintenance, transfection for transient expression as well as preparation of stable expression pools using CHO cell lines.
- Participate in the development of robust manufacturing processes (upstream and/or downstream) on candidate recombinant proteins.
- Perform routine analyses (CE-SDS, SDS-PAGE, ELISA, HPLC).
- Responsible for the analysis and documentation of experimental data (electronic laboratory notebook and files).
- Prepare protocols and reports on experiments performed.
- Responsible for the maintenance of laboratory equipment.
- Provide technical and scientific support during the development process.
- Participate in technology transfer activities.
- Use a quality-by-design (QbD) approach during all process development phases.
- At least a Bachelor of Science (B.Sc.) degree in biochemistry, biotechnology, life sciences or equivalent.
- A minimum of 2 years of experience in process development and/or manufacture of recombinant proteins or relevant experience in biotechnology or biopharmaceutical industry.
- Experience in purification of recombinant proteins (chromatography, TFF)
- Experience in mammalian cell culture and recombinant protein expression systems.
- Meticulous laboratory practice with good aseptic technique.
- Knowledge of downstream process technologies and protein purification.
- Ability to conduct experiments independently.
- Ability to work in multifunctional teams and in a dynamic environment.
- Experience in problem solving.
- Knowledge of Good Manufacturing Practice (GMP) is an asset.
- Effective communicator in writing and speaking.
Key Issues: Biochemistry, Process development, Chromatography, Recombinant Proteins expression