COMPLETE Technologist - Toronto, ON

Reference No. R2721672

Position Title: Technologist

Duration: Fixed-Term - Contract End Date: December 20, 2024

Department: References & Critical Reagents

Location: Toronto, Ontario

Sanofi Vaccines

Sanofi's global vaccines business unit partners with the public health, medical and scientific communities to improve access to life-protecting vaccines and increase vaccination coverage, while striving to develop new and improved vaccines to enhance health and well-being.

At Sanofi, we chase the miracles of science to improve people’s lives.  We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.

Major Activities of the Job:

Coordinates and performs routine standard testing:

Coordinates and performs Critical Reagent Qualification:

• Responsible for writing protocols and reports for test transfer and method validations.

• Executes testing including parallel testing and/or experiments, which may involve the improvement of standard tests performed in the department. Compiles data, performs preliminary statistical analysis and troubleshoots, if required.

• Co-ordination of testing schedules, as required.

• Updates all relevant documents as required, implements changes (e.g. SOP changes).

Documentation – Testing and Support Documents:

• Responsible for the timely, accurate completion and review /verification of test related documents to ensure on time delivery oftest results (e.g. LIMS, worksheets, logbooks, NuGenesis templates, Statistical calculation programs, verification of calculations and document entries for accuracy).

• Responsible for photocopying and delivery of approved documents and for the organizing and management of documents in accordance with department and corporate policies (binding worksheets, filing, compiling documents for archival).

• Review existing SOPs and initiates revisions or writing of SOPs, protocols, reports and test summaries as required.   (e.g. Qualification of test reagents, test transfers, test method validations).

• Responsible for ensuring SOP accuracy and timely updates, cascades changes to all staff affected by initiating SOP reviews. Ensures the accuracy of test documents and the timely update of worksheets and log sheets in the electronic worksheet management system as required.

• Responsible for updating and maintaining trending data as required. (e.g. Trending oftest controls, standards and products).

• Responsible for accurately compiling data for tests, products, trending for statistical reports, to support regulatory questions and / or submissions as required.​

• Responsible for ensuring accuracy of critical reagent inventory as related to responsibility.

• Responsible for collection and preparation of data for regulatory submissions and inquiries. ​

Maintenance of Quality Systems including adherence to GXPs and safety guidelines:

• Ensures compliance is maintained in all daily activities by following SOPs (divisional, department and test), protocols and procedures as they apply. Reviews SOPs and documents training.

• Responsible for identifying and notifying Manager of any laboratory non- conformances or quality notification. Files laboratory investigation reports, non-conformances, and quality notifications as required, provides required support documentation to expedite closures of events.

• Participate in root cause analysis to identify appropriate corrective actions for CAPA and events.

• Act as Change Control Initiator or Leader as needed.

• Responsible for creating and reconciling controlled testing worksheets in the Electronic Document Management system.

• Provide weekly testing information for general metrics to Manager.

• Ensures adherence to GMP guidelines and attendance at regularly scheduled updates.

• Ensures adherence to safety guidelines as outlined in corporate and site policies.  Responsible for reviewing MSDS sheets and ensuring compliance with requirements.

• Reports any major damages/abnormalities to Manager and/or notify Security/ Physical Plant, as well as initiate and follow-up on maintenance work orders. Maintains necessary immunization status up to date.

Test Transfer, Validation, & Implementation:

• Responsible for writing protocols and reports for test transfer and method validations.

• Executes testing including parallel testing and/or experiments, which may involve the improvement of standard tests performed in the department. Compiles data and performs preliminary statistical analysis and troubleshoots, if required.

• Co-ordination of testing schedules, as required.

• Updates all relevant documents as required, implements changes (e.g.  SOP changes).

Participation in specialized projects I experiments/ continuous improvement of existing tests:

• Participates in special projects, experiments or assays as required for existing products and new products (e.g. collaborative studies with regulatory agencies and organizations on method comparison, assay harmonization, new assay development).

• Attends team meetings providing technical expertise and performs the respective assays as required.

• Performs trouble shooting I test modification and experiments as required. Coordination of testing schedule, as required.

• Compiling, analyzing, performing preliminary statistical analysis on all relevant results and conclusions.

• Responsible for writing protocols, reports and SOP as required.

Training I skills upgrade I literature review:

• Complete on-the-job training according to current Lesson plans, and document as required. Attends and participates in relevant training sessions continuously.

• Review relevant SOPs / literatures continuously.

• Attends departmental weekly meetings.

• Participate in regularly scheduled GMP updates and safety training.

• Assists in training of new staff or existing personnel as required.

• Trains existing personnel in changes to new test methods once implemented. Performs literature searches to stay abreast of new technology.

No employee has a proprietary right to an activity or group of activities. Activities may be changed or reassigned to meet the needs of the operations.

Minimum Qualifications:

• Minimum four (4) years bachelor’s degree (Immunology, Cell Biology, Molecular Biology, Biochemistry) plus a minimum of (3) years of previous work experience.

• Preferred two (2) year master's degree (Chemistry, Biochemistry, Immunology, Biomedical Sciences or Molecular Biology), plus a minimum of 18 months of previous work experience.

• Standard and Advanced Immunological Techniques.

• Aseptic Techniques.

• Theoretical and Research related knowledge, Immunology, Biochemistry, Cell Biology, Virology.

• SAP I Network Systems Operation/ FMS /BAS

• SOP development.

• GMP/GLP.

• Computer knowledge hardware, software, interfaces (LIMS, NuGenesis, Basic troubleshooting).

• Mathematics / Statistics.

• Purification techniques. Accuracy, Organization, Judgment, Verbal and Written communication.

• In order to remain knowledgeable in the Immunology/ Immunochemistry/ Virology field, the analyst is required to keep up to date and upgrade skills as required on testing techniques, procedures and general Immunochemistry as well as to continue to improve and upgrade technical skills.

Hours Of Work:

• Inclusive from Monday to Friday, 8:00 a.m. – 4:00 p.m.

This is subject to change at any time and it should not be construed as limiting the right of the company to make such change to meet the requirements of the operation.

Pursue Progress.

Discover Extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com!

Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants.  Accommodations for persons with disabilities required during the recruitment process are available upon request.

Thank you in advance for your interest.

Only those candidates selected for interviews will be contacted.

Follow Sanofi on Twitter: @SanofiCanada  and on LinkedIn: https://www.linkedin.com/company/sanofi

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.