You are a passionate and creative scientist who is proficient in the planning and execution of experiments, maintaining equipment, preparing high-quality reagents and buffers, and performing various molecular biology and biochemistry laboratory techniques. You enjoy playing a critical role in a fast-paced lab environment and do not shy away from bench work to troubleshoot and optimize our next-generation assays. You are eager to actively contribute to our product development direction and present novel procedural and scientific concepts that will positively impact all aspects of the Vital ecosystem.
Develop, optimize and validate new assays for our diagnostic product pipeline
Design, execute, and meticulously document experiments in accordance with CLSI guidance
Construct, modify, and follow standard operating procedures in direct collaboration with the development team
Analyze clinical samples for assay verification and validation
Work collaboratively with various teams within the organization to ensure integration of reagents, consumables and instrumentation.
Help the team develop and achieve goals to meet ambitious timelines
Transfer methods to other internal or external partners and support collaborations through defensible result production and QC procedures
Work with QMS to ensure all development work is well documented and follows Vital’s quality processes and procedures.
Author, review, and hone our standard operating procedures (SOPs) to improve quality and accelerate our assay pipeline
Partner closely to provide assay development support to our research, manufacturing science, downstream formulation, and engineering teams to achieve performance requirements
Communicate effectively with peers and leadership to support decision-making, including summarizing results in reports and presentations
Contribute to departmental strategies and provide input on lab requirements and improvements
MSc or PhD degree in biochemistry, biology, immunology, hematology, or related field with 3 years of hands-on laboratory experience in industry.
Experience with execution of experiments in a wet lab preferably in an industry setting
Competency in immunochemistry and biochemical assays
Experience with verification and validation of assays (including design, writing and execution of pertinent SOPs) through regulatory agencies like the FDA, Health Canada or EU
Ability to communicate results and concepts clearly to fellow scientists and engineers
Ability to handle a diverse workload
High learning agility
GMP experience will be considered an asset
Familiarity with electronic QMS
Familiarity with the medical device industry and associated regulatory pathways;
Experience working with laboratory automation/liquid handling (i.e., TECAN);
Ability to write and maintain standard operating procedures;
Assay development experience with clinical samples;
Prior experience working in a fast-paced, start-up environment;
Appreciation of puns!