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.
What you'll need:- 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.
Bonus points for:- 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.
This role is a current, onsite vacancy.
