WHO WE ARE:

As part of the team at Evik Diagnostics Innovations you'll discover meaningful work within the medical device industry. You'll join a rapidly growing company where each day is different, and opportunities are approached with a team effort.

Evik was established in 2011 and is based in Kanata (in the same building as a brewery!) Our team are experts in the field of creating rapid, single-assay lyophilized beads for immunological and molecular diagnostics. Our DxSpheres are used for a wide variety of different testing applications including rapid PCR Covid test kits, and in environmental water testing laboratories. Our clients are located around the world and appreciate our transparency, communication, and ability to go the extra mile.

If you'd like to learn more about us and what we do, feel free to check out our website and watch our company video.

We are an ISO 13485 certified manufacturer and looking hire a Director of Technology Transfer. We provide exceptional customer service to our clients, and we are looking for a new team member to help us continue to exceed their expectations. You are an ideal candidate if you are looking to become part of a dynamic team.

WHO YOU ARE AND JOB OVERVIEW

We are looking for an experienced, creative, collaborative Technology Transfer team leader who is looking for an opportunity to make an impact on a team that thrives on change, process, and product improvement, and moves quickly.

Evik is growing, and we need an experienced cross-team collaborator to lead, guide and support a team of development scientists to ensure the most effective transition of on-going R&D projects into full scale production. This person must enable and contribute to team efforts while ensuring consistent compliance with product quality and customer requirements. We are looking for a candidate who likes and knows how to effectively communicate with clients and manage clients' expectations, enjoys problem solving and thrives in a developing environment, committed to excellence.

YOUR KEY RESPONSIBILITIES

• Lead the Technical Transfer team.
• Manage transfer of on-going R&D projects into the production phase, including development and scale-up processes to ensure new products manufacturability up to ISO 13485 standards.
• Oversee production documentation development including work instructions and process validation documents.
• Enable effective usage of technical expertise of Tech Transfer team for reagents mixing, dispensing, freeze-drying, process development and scaling up. Coaches team members on resolving technical issues and customers inquire.
• Oversee and maintain professional relationships with Evik's customers, review process development results, clients' assay performance data, advise customers on issues and deficiency resolution options, assist team members with client communications.
• Oversee overall project portfolio: coordinates with customers, reviews and approves timelines and scope of projects and assists Financial Department in creating quotes.
• Monitors project progress and timeline and supports team members in identifying and resolving problems and bottlenecks.
• Collaborates with R&D and Production departments to ensure availability of resources required to support an efficient technical transfer process.
• Provides technical support for the Production team at the early manufacturing stage.
• Provides technical expertise to investigate non-conformances and deficiency resolutions.
• Contribute to continuous improvements.
• Ensure team progress towards established goals, provide regular progress reports to CEO.
• Monitor employee performance to ensure employee's goals are met and provide feedback to engage and improve individual performance and team collaboration.
• Review protocols and reports describing analytical assays, contributing to quality control procedures.

YOUR EDUCATION, EXPERIENCE

• Exceptional English verbal and written communication skills.
• Outstanding ability to organize people, processes and work environment.
• Extensive experience in formulating, producing, and testing different assay methods; formulation design for various active ingredients with selected excipients and stabilizers, especially for stabilizing enzymes in “dry chemistry” or freeze-dried/lyophilized form.
• PhD in chemistry, biochemistry, molecular biology, biophysics, bioengineering, or a related field
• 15+ years of industrial experience in diagnostic assays and reagents development, technology transfer and scaling up.
• Minimum 5 years experience in a management role.
• Freeze-drying expertise is an asset.