Scientist - Process Development Immunoassay
About you:
You are a detail-oriented engineer or scientist with a strong foundation in biological or chemical sciences and a growing depth of experience in immunoassay scale-up and technology transfer. You are motivated, analytical, and comfortable bridging the gap between R&D innovation and commercial manufacturing within a fast-paced, regulated environment. You bring hands-on experience navigating cGMP or ISO 13485 guidelines, possess a natural knack for rigorous technical writing, and are eager to take on greater technical ownership of QMS workflows, process improvements, and manufacturing transitions.
What you'll do:Lead technology transfer and scale-up activities for immunoassay-based products (e.g., ELISA, lateral flow) from development/pilot scale to commercial GMP manufacturing.
Author and optimize technical documentation required for manufacturing, including Batch Production Records (BPRs), Master Batch Records (MBRs), Standard Operating Procedures (SOPs), and Tech Transfer Reports.
Manage QMS workflows by leading technical investigations for process deviations, Out of Specification (OOS) results, and implementing corrective and preventive actions (CAPAs).
Drive process improvement and optimization efforts to enhance assay robustness, scale-up yield, and manufacturing reproducibility using root-cause analysis (RCA) and data-driven methodologies.
Ensure strict compliance of manufacturing processes and transfer workflows with cGMP and ISO 13485 regulatory standards.
Design, execute, and analyze experiments specifically geared toward process validation, scale-up modeling, and bridging studies.
Collaborate cross-functionally as the primary technical bridge between R&D, Quality Assurance, Engineering teams, and Manufacturing Operations to ensure seamless product scaling and timeline adherence.
Provide hands-on technical support during manufacturing scale-up, validation runs and troubleshooting campaigns.
Bachelors or Masters Degree in chemistry, biochemistry, biophysics, bioengineering, immunology, or a related field with 3+ years of experience in an industry R&D setting with focus on reagent process development, or Ph.D with 1+ years of similar experience.
industry experience directly within process development, technology transfer, and/or manufacturing support in a regulated GMP / ISO 13485 environment.
Strong understanding of immunoassay principles (such as ELISA, lateral flow assays) coupled with experience scaling these processes from the bench to production.
Direct experience with Quality Management Systems (QMS), technical writing for manufacturing, and investigating deviations or OOS events.
Hands-on experience interpreting scale-up data, troubleshooting process vulnerabilities, and optimizing automated laboratory instrumentation or production tools.
Excellent technical writing and verbal communication skills with a sharp eye for document compliance and detail.
A collaborative mindset with the ability to take full ownership of transfer timelines and make data-driven decisions under pressure.
Advanced technical exposure to automated liquid handlers, nanoparticles, microfluidics, protein conjugation, or statistical analysis (e.g., JMP, Minitab, DOE).
Prior experience launching a commercial product or directly supporting regulatory submissions.
Familiarity working in a fast-paced startup environment where you have creatively solved scaling or compliance bottlenecks.
Positive, team-oriented attitude.
The compensation range for this role is $80,000 - $95,000 CAD. Compensation will be determined based on the individual’s demonstrated experience, education, training, relevant certifications or licensure, and other applicable business and organizational factors.
Thi…
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