North York, Ontario
Documentation Specialist (Life sciences)
Hybrid in North York
The candidate will support and work closely with the Lead Downstream Scientist working on the development of a downstream purification process for a non-live Containment level 3 biological organism under the New Vaccines platform in Manufacturing Technology. Specifically, this role encompasses:
Generation of downstream purification feasibility protocols and reports
Coordinating activity in the lab with multiple teams for downstream studies, execution and sample handling
Provides scientific input with data analytics and problem solving for downstream feasibility studies
Supports internal product and technology transfer ensuring the application of product knowledge gained through development phase to the needs of industrial manufacturing.
• Life Sciences, Pharmaceutical Sciences, Bioengineering degree with a minimum of 3 years of industrial experience
• Good knowledge of vaccines/biologics, Quality principles and GMP.
• Demonstrated expertise in downstream purification processes and process industrialization
• Some knowledge of bacterial, cell & viral culture and good knowledge of technical areas specific to downstream purification of biologic products. Knowledge of freeze drying is an advantage.
• Understanding of the key quality attributes and influences of physical and chemical stability of biologics.
• Excellent verbal and technical writing skills
• Must be able to work quickly with a high degree of accuracy.
• Must possess sound interpersonal and information gathering skills
• Excellent data analytics skills
• Working knowledge of Project Management or PMP certification is an advantage.