Scientist - Process Development Immunoassay

VitalBio; Oakville; On-site; CAD 80,000 - 95,000; Full time

Job summary

Vital Bio in Oakville, Ontario seeks an experienced engineer or scientist to lead technology transfer and scale-up of immunoassay products from development to commercial GMP manufacturing.

You will author manufacturing documentation, manage QMS investigations, drive process improvements, ensure cGMP/ISO 13485 compliance, and collaborate across R&D, QA, engineering, and Manufacturing. The role includes hands-on support during scale-up, validation, and troubleshooting.

Qualifications

• Degree in chemistry/biochemistry/biophysics/bioengineering/immunology with hands-on reagent process development
• Experience in regulated GMP/ISO 13485 environments
• Strong immunoassay knowledge (ELISA, lateral flow) and scale-up experience

Responsibilities

• Lead technology transfer and scale-up for immunoassay products from development/pilot to commercial GMP manufacturing
• Author and optimize manufacturing documentation (BPRs, MBRs, SOPs, Tech Transfer Reports)
• Manage QMS workflows by leading investigations for deviations and CAPAs
• Drive process improvements using RCA and data analytics to improve robustness and reproducibility
• Ensure compliance with cGMP and ISO 13485 in transfer workflows
• Design and execute experiments for process validation, scale-up modeling, and bridging studies
• Collaborate with R&D, QA, Engineering, and Manufacturing to ensure timely scaling
• Provide hands-on technical support during scale-up, validation runs, and troubleshooting

Skills

Immunoassay scale-up

Technology transfer

QMS workflows

cGMP/ISO 13485

Technical writing

Data analysis

Cross-functional collaboration

Root-cause analysis

Education

Bachelor's or Master's in chemistry/biochemistry/biophysics/bioengineering/immunology

PhD with 1+ year relevant experience

Job description

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.

About Vital Bio

Vital is revolutionizing point-of-care diagnostics with our VitalOne platform, delivering real-time care wherever patients are. Our mission is to democratize health technology, making healthcare more accessible and proactive.

Our global team of experts spans chemistry, software, engineering, and microfluidics. We thrive on change, operate on trust, and value diverse perspectives. Our growth-minded culture empowers front-line decision-making and fosters impactful work.

We seek tenacious, bold individuals ready to transform healthcare. At Vital, your talent will make a difference as we work to ensure everyone has access to care when and where they need it.

Vital Biosciences Inc. is an equal opportunity employer and values diversity in the workplace. We are therefore happy to accommodate any individual needs in keeping with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act. If you require accommodation in order to participate in our hiring process, please contact us to make your needs known in advance

As part of our recruitment process, we may use automated or AI-supported tools to assist with application review and screening. These tools are used to support, not replace, human decision-making. Final hiring decisions are always made by our hiring team.