Scientist II, Immunogenicity
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Monthly Salary:
Posted on:
17 hours ago
Vacancies:
1 Vacancy
Job Summary
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 return well 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 primaryresponsibilitiesinclude:
Responsabilities
Client Communication and Relationship Management
- Proactively inform the manager and clients of study progress results and issueswhether 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 nonconformities 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 followingminimum qualificationsfor this role:
- Holder of a degree in immunology biochemistry molecular biology or a related field (. or Ph.D.);
- Experience in immunological bioanalytical testing in a regulated (GLP) environment;
- Indepth knowledge of GLP and OECD FDA EPA JMHW guidelines;
- Handson 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 highquality 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 milestonebased 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 nonconformities 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:
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.
With over 20000 employees within 110 facilities in over 20 countries around the globe we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our clients unique challenges. Our client base includes global pharmaceutical companies biotechnology companies government agencies and hospitals and academic institutions around the world.
At Charles River we are passionate about our role in improving the quality of peoples lives. Our mission our excellent science and our strong sense of purpose guide us in all that we do and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.
Were committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance 401K paid time off stock purchase program Health and wellness coverage employee and family wellbeing support programs and work life balance flexibility.
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.
It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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 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 .
Required Experience:
IC
Key Skills
- Laboratory Experience
- Immunoassays
- Machine Learning
- Biochemistry
- Assays
- Research Experience
- Spectroscopy
- Research & Development
- cGMP
- Cell Culture
- Molecular Biology
- Data Analysis Skills
About Company
Find your moment to make a significant impact on global health with a career at Charles River
