Senior Scientist, Product Development

Reporting to the Director, Scientific Affairs, the Senior Scientist, Product Development will serve as a Technical Lead who will help lead the design and development of new In‑Vitro Diagnostic technologies from initial concept creation through in‑house verification and into clinical validation. This role will focus on product development, including but not limited to, the development of new IVD’s for the detection of infectious diseases.

This position will provide direction to the development process working through a design phase gate system from the research phase, through design development, official verification and validation testing to hand off to the design transfer team. You will work as a part of a cross functional team including Scientific Affairs, RA, QA, QC and production.

This position demands strong project management leading their team and resources to complete projects on time and within established budgets. Oversee complex product development objectives transitioning from feasibility to regulatory approval.

• Scientific Planning, laying out a clear implementation pathway that aligns development strategy and company priorities, including attention to and monitoring of timelines
• Development of design inputs based on solid scientific research and exploration into region specific regulatory requirements
• Specific activities include developing assay specific reagent kits, reagent and reagent formulation, control development and test optimization
• Lead the design, development and clinical validation that supports product testing, regulatory approval by the FDA, Health Canada, Notified bodies, WHO and others.
• Oversight of day‑to‑day lab work with team to effectively and efficiently drive timely milestone achievement
• Daily activities will include, but are not limited to, hands‑on benchwork, mentoring and guiding less experienced staff, design review, product evaluation, support design transfer from R&D to manufacturing
• Lead by example, providing leadership within Scientific Affairs Team and Company, including product development planning and execution, quality, regulatory compliance, technical support and issue resolution, improving process efficiency, application of Design of Experiment and statistical tools for the development of design specifications
• Required to work across multiple projects, simultaneously to achieve aggressive milestones
• Work effectively across multiple functions to align timeline commitments and objectives, manage interdependencies, and achievement of milestones

• MS or PhD in a related field, Minimum of 5‑7 years of industry experience
• Direct product development experience of rapid IVD devices with successful commercialisation experience is highly valued
• Broad scientific knowledge and strong critical thinking skills, excellent attention to detail including accurate and thorough record keeping, technical report writing, experience in clinical test development in clinical research environment, and the ability to anticipate, recognize and resolve technical problems. GLP and GMP experience.
• Experience and knowledge preferred: blood biology, biochemistry/protein chemistry, lateral flow and flow through devices, in‑vitro diagnostic assay and product development, clinical collaborations, regulatory requirements for product development, phase gate design processes
• Organized and detail‑oriented

• A competitive compensation package
• Bonus day off with pay on your birthday every year!
• Full‑size in‑house fitness gym and shower facilities
• Complimentary reserved parking
• Opportunity to work with industry experts who are motivated and passionate about what they do but know how to have some fun
• A chance to show off your dance moves and singing voice at the company parties and jump in to score a victory or lead the way in our outdoor games at the summer barbeques
• The opportunity to join an ‘off the charts’ foodie culture in our large kitchen and try out your favourite recipes or enjoy the culinary delights as they hit the share table

The annual base salary for this job ranges from:

$90,000-$100,000

bio Lytical’s pay range is based on multiple factors…