Scientist II, Immunogenicity

Charles River Labs; Senneville; On-site; CAD 67,000 - 72,000; Full time

Job summary

A leading contract research organization is looking for a Scientist II in Immunogenicity in Senneville, Canada. This role requires leading bioanalytical programs in a GLP environment, ensuring scientific quality and compliance while fostering client relationships. Candidates must hold an M.Sc. or Ph.D. in a relevant field and have experience in immunological testing. The position offers a permanent full-time schedule, with an annual salary of CAD 67-72k and comprehensive benefits including a shuttle service and gym access.

Benefits

Annual performance bonus

Paid development training

Free onsite gym

Employee assistance program

3 weeks vacation

10 personal days

Qualifications

• Degree in a relevant field (M.Sc. or Ph.D.) is mandatory.
• Experience in GLP-compliant bioanalytical testing is required.
• Knowledge of FDA and OECD guidelines is essential.

Responsibilities

• Lead and execute bioanalytical immunology programs.
• Maintain regulatory compliance and ensure quality.
• Supervise and mentor team members in GLP practices.

Skills

Immunological bioanalytical testing

Client communication

Regulatory compliance

Mentoring and training

Data integrity

Project management

Education

M.Sc. or Ph.D. in immunology, biochemistry, molecular biology, or related field

Tools

ELISA

Watson

SoftMax Pro

Biomek FX

Hamilton STAR

Job description

Overview

For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

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:

Responsibilities

• 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.

Qualifications

• 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 : [phone]
• By email : [e-mail]
• By mail : 22022 route Transcanadienne, Senneville, QC, H9X 1C1

About Safety Assessment

Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.

About Charles River

Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

Equal Employment Opportunity

Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.

If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to [e-mail]. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

For more information, please visit www.criver.com.