Product Development Associate
City: Richmond, BC, Canada
Department: Product Development, Research & Development
Position: Permanent, Full Time
# of Openings: Two
bioLytical Laboratories, listed as Business in Vancouver’s fastest growing companies, is a privately-owned Canadian company focused on the research, development and commercialization of rapid, point-of-care in vitro medical diagnostics using its proprietary INSTI technology platform.
With a world-wide footprint of regulatory approvals including US FDA approval, Health Canada approval and CE mark, bioLytical markets and sells its INSTI HIV test globally and INSTI HIV/Syphilis Multiplex test in Europe. The INSTI product line provides highly accurate test results in 60 seconds or less, far faster than the 15-20 minutes required for tests based on lateral flow technology.
As a nimble and innovative company, bioLytical has an active R&D department with a pipeline that includes INSTI tests for diseases such as Hepatitis C and Syphilis, among others. The company also provides contract services to adapt the INSTI platform to meet custom functional and technical diagnostic testing requirements.
Reporting to the Product Development Manager, within the Research & Development department, the Product Development Associate plays a key role in the design and development of new bioLytical rapid point of care tests. You live the INSTI core values through and through.
- INNOVATION in what we do, how we do it and how we think: Contributes new ideas, challenges the status quo, takes 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 passion for INSTI, our people and our projects. Is not complacent, shares knowledge freely, exhibits awareness of self, their surroundings and the business.
HOW YOU WILL CONTRIBUTE:
- Research and understand the role of proposed new products to be added to the bioLytical product portfolio
- Research and provide input into design requirements for new products
- Translate design requirements into documented design verification and validation test plans
- Execute design verification and validation test plans as required
- Design and execute required stability studies
- Troubleshoot test results and design challenges as required
- Initiate and maintain design history files during project development
- Participate in risk management activities related with the product under development
- Translate design outputs into procedures, testing methods and quality control release criteria
- Assist with designing external verification and validation studies (retrospective or prospective studies)
- Analyze and summarize data and write reports
- Assist with providing data for meta-analysis white papers and publishing of peer review papers
- Assist in other Research and Development or Product Support activities as required
- Assist with training of laboratory or other related personnel
WHAT YOU BRING:
- Bachelor degree in a life sciences discipline, preferably in medical technology, microbiology, biochemistry, chemistry, biology or related science.
- Minimum 2 years’ experience in a research or clinical laboratory preferred
- Knowledge of or experience with GLP, GMP work desired
- Excellent interpersonal skills, oral communication skills, and written communication skills are required
- Must be able to work independently following a brief period of specific technical training
- Must have strong analytical and technical writing skills
- Excellent computer skills (MS Office, Access, Excel)
- Organized and detail-oriented
WHAT WE OFFER:
- A competitive compensation package
- Extended health benefits including dental, optometry, RMT, etc.
- Flexible working hours
- Paid vacation
- bonus day off WITH pay on your Birthday every year!
- Paid sick days
- Complimentary reserved parking
- Complimentary shuttle to/from the office and River Rock Hotel
- Opportunity to work with industry experts who are motivated and passionate about what they do but know how to have some fun
- Oh and you will also have a chance to show off your dance moves and singing voice at the Christmas parties, lead in lawn bowling or volleyball at the summer barbeques and devour cake at the monthly birthday celebrations
HOW TO APPLY:
Send your cover letter and resume to firstname.lastname@example.org or send us an email if you need additional details about this opportunity.
We are an equal opportunity employer and invite applications from all qualified individuals.