Product Development Manager
Location: Richmond, BC, Canada
Department: Research & Development
Position: Permanent, Full-Time
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 directly to the Chief Operating Officer, the PD Manager is an important leader within the R&D department and the company as a whole. You are a timeline and project managing extraordinaire who knows design control and Gantt charts inside out . . . but you can roll up your sleeves and do some of the doing as we all pitch in on this small team. You are a master of details and nothing gets by you as you manage and direct the design and development of new rapid point of care tests on the INSTI platform and beyond . . . but you can see the forest from the trees, so you know not to sweat the small stuff, because your experience outside of academia has taught you that a commercialized product generates cash for reinvestment into more development projects. Although you lead with science, the numbers don’t elude you. You are a wizard with budgets including planning for materials, equipment and personnel. 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:
- Execute departmental strategy for the development and delivery of a world class INSTI multiplex rapid point of care product portfolio
- Manage the day-to-day operation of the PD department; Plan and manage personnel and equipment requirements. Manage project planning and project tracking through a Phase Gate model for selected products
- Responsible for managing project budget and reporting to management, governmental/granting agencies as required
- Research and understand the role of proposed new products to be added to the bioLytical product portfolio and source important publications
- Research and provide input into the intended use and design requirements for new products. Determine and execute improved technologies used by suppliers, potential partners, competitors and customers.
- Lead Design Control activities and assist in the design and documentation for developing products
- Review early concept designs completed by Research
- Troubleshoot test results and design challenges as required
- Prepare preliminary design specifications and draft design verification and validation test plans documentation
- Execute design verification and validation test plans as required
- Design and execute required stability studies
- Initiate and maintain design history files during early phases of product development
- Participate in risk management activities related with the product under development
- Lead designing of external verification and validation studies (retrospective or prospective studies)
- Analyze and summarize data and write reports including assisting with regulatory submissions
- Work with Technical Operations and Manufacturing team to translate design outputs into procedures, testing methods and quality control release criteria for large scale production.
- Analyze data for meta-analysis white papers and publishing of peer review papers
- Suggest training tools to enhance employee performance and skill development
WHAT YOU BRING:
- PhD or a Master’s degree in a life sciences discipline (preferably biochemistry, microbiology, biology or related science) with a minimum of 3-5 years’ supervisory experience in a medical device industry environment
- Knowledge of and experience with GLP, GMP work and ISO 13485
- Working knowledge of generating and monitoring project budgets and SR&ED.
- Excellent interpersonal skills, oral communication skills, and written communication skills are required
- A can-do, winning attitude and demonstrated track record of being a strong leader
- Must have strong analytical and technical writing skills
- Must be able to work independently following a brief period of specific technical training
- Excellent computer skills (MS Office, Access, Excel)
- Organized and detail-oriented
- Experience in writing studentship, fellowship and/or research application is preferred
WHAT WE OFFER:
- A competitive compensation package
- Extended health benefits including dental, optometry, RMT, etc.
- Flexible working hours
- Paid vacation (plus you get a bonus day off WITH pay on your birthday every year!)
- Paid sick days
- A complimentary reserved parking spot
- 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
BioLytical Laboratories Inc. offers a challenging, enriching work environment. To apply for this opportunity, please send your resume and current salary to firstname.lastname@example.org.
We are an equal opportunity employer and invite applications from all qualified individuals.