R&d Scientist Iii

In 1992, Precision BioLogic began developing an integrated line of high-quality frozen controls, calibrators, and reagents - the cryo_check_ brand - for use in clinical hemostasis laboratories. Through years of extensive collaboration with lab managers and technologists, we developed our range of innovative _in vitro_ diagnostic products and expanded our distribution network beyond North America. Known for our integrity, simplicity, and relevance, our cryo_check_ products have become synonymous with quality and certainty in labs around the globe. Today, with our laboratory, biotech, and pharmaceutical partners, we are developing new products to improve patient outcomes by addressing current and future challenges in the diagnosis and therapeutic monitoring of coagulation and hemostasis disorders. As Precision BioLogic continues to grow, we are looking to add an R&D Scientist III to our team.

**Role Description**

Your responsibilities will include:

- Developing research and development plans and protocols for new product development projects using scientific methods and experimental design
- Leading R&D project teams in the design and execution of experiments required for product development activities
- Analyzing experimental data and provide timely, accurate, and concise summaries and reports
- Authoring and reviewing grant proposals, SOP’s, project summaries, scientific and technical reports
- Providing leadership, mentorship, and technical support to R&D team members
- Keep abreast of scientific/technological developments and share new ideas with the team
- Perform timely documentation of all phases of research and development according to current company GLP and SOPs
- Assisting in the transfer of new technologies, product and manufacturing processes into and out of operations
- Writing and providing support for writing investigational experiment (IE) protocols and reports
- Performing other related duties as assigned

**Y**our Qualifications*

As the R&D Scientist III you are a natural communicator and collaborator with experience in assay development, ideally as it relates to hemostasis and coagulation. The thought of developing products that improve the patient experience excites you, and your past work experiences allow you to problem solve while thinking outside the box. You can clearly deliver a message to a wide and varied audience and your knack for building relationships makes you a valuable addition to any team.

Your qualifications include:

- A PhD in Hematology or a related field and 10+ years of industry experience
- Experience in the development of in vitro diagnostic assays, such as immunoassays
- A strong knowledge of formulation and production workflow which allows you to scale up R&D work into the production phase
- Demonstrated leadership experience with a proven ability to mentor junior staff
- Strong experience with experiment design and design of research by providing detailed research plans that address design requirements
- Experience working within design control processes and familiarity with GMP
- Excellent understanding of current Good Laboratory Practice (cGLP) as well as knowledge of ISO 13485 standards, FDA 21CFR820 regulations, and CLSI & ISTH guidelines
- Experience with performing data analysis using a statistical software package; R for Data Science ideally, or other such software.
- You are a self-starter, innovative thinker and are able to perform with mínimal supervision
- You are a strong communicator and possess interpersonal skills that provide insight into the processes used to achieve results of assigned tasks

As the R&D Scientist III you will be joining a team that is passionate about providing a superior product and experience to their customer and that values its employees and positive team relationships. You will be given the opportunity to use your leadership skills and work as part of a strong team on projects where you will see the whole journey of the product development lifecycle. The culture at Precision BioLogic sets us apart and staff feel they are given the latitude to make decisions and think creatively. Additionally, our size allows us to nimbly respond to market opportunities and as part of our team you will have the opportunity to be part of the development of products that allow for better patient diagnosis and care.
Precision BioLogic has created a highly participatory work environment with plenty of opportunity to contribute to the company’s success. If you are interested in joining our team, please submit your résumé in confidence, along with compensation expectations.

**Benefits**:

- Casual dress
- Company events
- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Flexible schedule
- Life insurance
- On-site gym
- On-site parking
- Paid time off
- Profit sharing
- RRSP match
- Vision care
- Wellness program

Schedule:

- 8 hour shift

COVID-19 considerations:
We follow all Public Health