Scientist II, Immunogenicity

Job Summary

As a Scientist II for our Immunogenicity team located at the Senneville site, you will be primarily responsible for leading, planning, and executing bioanalytical immunology programs (including validation and execution of immunogenicity assays) in a regulated environment, ensuring scientific quality, GLP compliance, and proactive communication with clients.

In this role, primary responsibilities include:

Responsabilities

Client Communication and Relationship Management

• Proactively inform the manager and clients of study progress, results, and issues—whether positive or negative;
• Lead or participate in client teleconferences; prepare talking points, supporting documents, and action follow-ups;
• Present results (data, analyses, conclusions, limitations) clearly, accurately, and with proper context;
• Write scientific summaries, technical reports, and formal communications aligned with regulatory and internal expectations.

Study Planning, Organization, and Execution

• Develop and maintain Gantt charts and study timelines; define milestones and critical paths;
• Drive milestone achievement (quality, timelines, costs) and rebalance priorities and resources based on risks and urgencies;
• Allocate and coordinate resources (equipment, reagents, personnel) to ensure study execution;
• Adapt plans to meet client and organizational needs while maintaining compliance and traceability.
• Promote teamwork in a matrix environment, ensuring collaboration across laboratories, quality control, quality assurance, and regulatory affairs.

Technical Leadership and Talent Development

• Supervise, mentor, and train team members (specialists/junior staff) on methods, SOPs, GLP, and good documentation practices;
• Share methodological expertise (immunoassays, automation, analyses) and support continuous improvement;
• Critically review study plans, data, and reports; ensure scientific robustness and narrative consistency.

Regulatory Compliance and Quality (GLP)

• Operate under GLP and ensure compliance with applicable standards (OECD, FDA, EPA, JMHW);
• Identify and document non‑conformities, deviations, and GLP risks; define appropriate CAPA;
• Contribute to clinical immunogenicity assay validations (plans, acceptance criteria, validation reports);
• Collaborate closely with Quality Assurance on internal/external audits and document management.

Scientific Execution – Immunological Bioanalysis

• Design, validate, and execute immunoassays (ELISA, MSD/Mesoscale, Gyros) on the corresponding platforms in accordance with SOPs;
• Perform specialized techniques: acid dissociation, ACE (affinity capture elution), antibody purification;
• Implement automation and standardization on platforms such as Biomek FX and Hamilton STAR (methods, scripts, qualification);
• Conduct investigations, root cause analyses, and implement sustainable corrective actions.

Data Management and Integrity / Software

• Prepare and verify datasets and results intended for clients and inspections;
• Use specialized software, including Watson and SoftMax Pro (plate reading/processing), ensuring ALCOA+ data integrity;
• Standardize files, metadata, and reports to support traceability and reusability.

Key Elements

We are looking for the following minimum qualifications for this role: 

• Holder of a degree in immunology, biochemistry, molecular biology, or a related field (M.Sc. or Ph.D.);
• Experience in immunological bioanalytical testing in a regulated (GLP) environment;
• In‑depth knowledge of GLP and OECD, FDA, EPA, JMHW guidelines;
• Hands‑on experience in clinical immunogenicity assay validation;
• Proficiency with immunoassays (ELISA, MSD/Mesoscale, Gyros) and techniques such as acid dissociation, ACE, and antibody purification;
• Experience with automation (Biomek FX, Hamilton STAR) and assay validation;
• Practical experience using Watson and SoftMax Pro; adherence to ALCOA+ principles for data integrity;
• Strong documentation rigor and high‑quality scientific report writing skills;
• Excellent ability to explain complex results, both orally and in writing;
• Comfortable with client presentations; constructive management of expectations and risks;
• Proficiency in milestone‑based planning (Gantt charts) and progress tracking;
• Strong ability to prioritize, arbitrate, and reallocate resources when needed;
• Demonstrated effectiveness in a matrix organization; ability to mobilize multidisciplinary teams;
• Experience mentoring/training junior staff; strong quality culture and continuous improvement mindset;
• Ability to identify non‑conformities and lead CAPAs;
• Strong understanding of English (oral and written). Bilingualism (French and English) is an asset.

Role Specific Information:

• Location: 22022 route Transcanadienne, Senneville, QC, H9X 1C1; 
• Transportation: We offer a free shuttle service from the Sainte-Anne-de-Bellevue train station and John Abbott College to the Senneville site. Free parking. Electric vehicle charging station;
• Annual bonus based on performance;
• Schedule: In person, Monday to Friday, Day schedules;
• Permanent position as of the hiring, full-time 37.5hrs per week.
• Annual Salary range: 67-72k

Why Charles River ? 

• We offer competitive benefits and advantages from day one to support your well-being;
• Paid development training;
• Free gym on site; 
• Employee and family assistance program;
• Excellent welcome program for new employees as well as in-house advancement and career; development opportunities;
• Access to a doctor and various health professionals (telemedicine);
• 3 weeks’ Vacation & 10 Personal day policy;
• Many social activities!

If you are interested in contributing to the well-being of our communities, not only across the country but around the world, please join us. This is Your Moment.

Contact information :

• By phone : (438)469-8575
• By email : annabelle.landry@crl.com
• By mail : 22022 route Transcanadienne, Senneville, QC, H9X 1C1