Job Description

Reporting directly to the R&D Manager, 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\xe2\x80\x99s 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. *
HOW YOU WILL CONTRIBUTE*

• 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

WHAT YOU BRING

• 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
• 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.

WHAT WE OFFER

• A competitive compensation package
• Extended health benefits including dental - 100% employer contribution
• Flexible working hours
• Paid sick days
• 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 \xe2\x80\x98off the charts\xe2\x80\x99 foodie culture in our large kitchen and try out your favourite recipes or enjoy the culinary delights as they hit the share table

ABOUT BIOLYTICAL BioLytical is a rapidly growing biomedical company. The company\xe2\x80\x99s vision is to develop innovative rapid diagnostic test to help fight several diseases around the world. The company aims to be vertically integrated, producing in house all the materials required for the testing device, from recombinant protein production to the final kit. Thus, bioLytical is looking for people eager to build and help shape the company of the future. bioLytical Laboratories Inc. is a privately-owned Canadian company focused on the research, development and commercialization of rapid in-vitro medical diagnostics using its proprietary INSTI\xc2\xae technology platform. bioLytical has won several local and industry awards, including BC Exporter of the Year in 2019. We have been named Lifesciences BC\xe2\x80\x99s Growth Stage Med Tech Company of the Year and have been featured on BC\xe2\x80\x99s Fastest Growing Companies six years in a row, including the Globe and Mail\xe2\x80\x99s Fastest Growing Companies list in 2020. bioLytical moved to a significantly larger, state-of-the-art facility in Richmond in 2020 to accommodate the extraordinary growth achieved through our team. *
CORE VALUES*
INNOVATION in what we do, how we do it and how we think: Contributes new ideas, challenges the status quo, takes the initiative on projects.
NEVER SAY NEVER: Stays engaged until the goal is reached or project is completed. Overcomes barriers. Cares so much about the task at hand that the impossible is made possible.
SENSATIONAL to our clients, to our partners, to each other: Spirited team player, who adapts to new situations quickly and is beyond reliable.
TAKES OWNERSHIP of goals, decisions, actions, and results: Arrives on time and prepared, leads by example, follows through on commitments.
INSPIRED to excel: Demonstrates a passion for INSTI, our people and our projects. Is not complacent, shares knowledge freely, exhibits awareness of self, their surroundings, and the business. #productdevelopment #R&D #lifesciences #diagnostics #medicaldevice #assaydevelopment Job Type: Full-time