Lateral Flow Senior Process Engineer

Our client is poised to disrupt the allergy diagnostic market with the introduction of a point-of-care testing system that dramatically enhances the speed, convenience, and accuracy of allergy testing.

Their development centre is in Ontario, Canada, where they are building their future success based on the talent, energy, and commitment of over 30 professionals and team members.

As they continue to grow and move to product release, they are seeking an experienced, talented, and meticulous senior process engineer to join their growing team.

If you join this company, you will be part of a multidisciplinary team of scientists, engineers, and businesspeople in a dynamic environment.

You will have the opportunity to join a team bringing a ground-breaking new allergy product to the market.

Responsibilities and Duties :

The Process Engineer’s responsibilities include managing the transition of R&D assays into an ISO 13485 compliant quality system and coordinating manufacturing activities for commercialization.

This includes collaboratively characterizing the manufacturing processes with R&D staff to establish process capability and reproducibility framework for test production.

The candidate will work closely with senior management to develop strategic plans for product manufacturing and expanding operations.

Requirements / Skills :

• Bachelor's, master’s, or PhD degree in engineering, chemistry, biochemistry, bioengineering, or a related field with experience in process development.
• 5+ years of experience in immunoassay development
• Demonstrated track record of solving challenging issues with assay design, development, and optimization
• Excellent organizational and project management capabilities to facilitate internal and external scientific interactions
• Strong verbal and written communication skills for generating high-quality proposals, presentations, and reports
• Ability to multitask, manage multiple projects, and rapidly learn new techniques and approaches.
• Ability to work effectively in a cross-disciplinary environment.
• Must excel in a fast-paced environment
• Familiarity with Medical device development and working in FDA QSR and ISO 13485 environments
• Demonstrated track record of bringing diagnostics from feasibility through transfer to manufacturing
• Direct, hands-on experience generating analytical assay development, optimization, and validation data packages in accordance with regulatory requirements
• Previous experience with ELISAs or LFIA antibody conjugation, protein purification, and fluorescent labeling
• Experience with cGMP / ISO 13485 compliant quality systems
• Drafting and release of standard operating procedures and batch production records
• Highly motivated and innovative problem solver able to independently design, execute, troubleshoot, and interpret experiments within a cooperative matrixed team environment.

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