Sanofi Pasteur, the vaccines division of the Sanofi Group, is Canada’s oldest and largest vaccine company, with a proud heritage and a strong commitment to public health. Celebrating its 100th year in 2014, Sanofi Pasteur continues to provide essential, life-saving vaccines to millions around the world, for the prevention and treatment of infectious diseases.
Sanofi Pasteur Limited, located in Toronto, is one of the company’s four major R&D and manufacturing sites, and home to Sanofi Pasteur’s North American Centre for Analytical and BioProcess R&D. These and other activities offer employees diverse opportunities for personal and professional growth. Our company attracts some of the best minds in the business from across the globe. Our 1,400 employees give us their best, and we offer the best in return.
Sanofi Pasteur Limited is accepting applications for a talented and results driven Scientist to join the Biochemistry Platform of our Analytical R&D (ARD) Department. The incumbent will develop, qualify, and validate test methods for new vaccine product characterization, stability, and release testing. The incumbent will additionally manage the transfer of analytical test methods from and to internal and external laboratories. The incumbent will also be responsible for providing project support, scientific expertise, and supervision of and task assignment to staff where required.
- Develop new or improved test methods for new vaccine candidate characterization, stability testing and release. Understand requirements for test methods and project milestones by interacting with Project Teams, analytical working groups and Platform directors. Recommend and lead implementation of next steps in projects relative to product testing and characterization. Maintain GMP compliance, where required, in all testing programs. Review and approve test method technical reports.
- Qualify/Validate analytical test methods in support of characterization, release, and stability testing. Design and lead the qualification/validation strategy and review and approve qualification/validationprotocols. Present results to Project Team, Platform director or regulatory agencies upon request. Review and approve qualification/validationreports.
- Oversee the transfer of analytical test methods in support of release and stability testing into receiving departments. Design and approve transfer protocols. Ensure the training of analysts who receive the assay. Review and approve method transfers from external and internal labs to design method transfer plans. Review and approve test transfer reports.
- Participate and contribute to analytical working groups as required to support project milestones and provide strategic review and direction, including detailed plans and risk assessments. Author sections of regulatory documents, position/strategy papers as required.
- Review scientific literature for application to vaccine development and characterization and make recommendations. Contribute to development of new platform technologies. Communicate research findings to the scientific community and to Senior Management by attending international scientific meetings, presenting research results, writing papers for publications in scientific journals, preparing patent applications.
- Supervise and monitor compliance with employment and health & safety legislation to ensure that employees are trained and work within the policies, procedures and regulations. Supervisory responsibilities include experimental design, execution of tests, and report writing to support release of clinical lots and product characterization following GMP requirements.
Education & Experience:
- Ph.D. in Biochemistry or closely related field, with a minimum of two (2) years of relevant work experience in vaccine development or relevant field; or, M.Sc. with a minimum of four (4) years relevant work experience.
- Specific experience in the development and execution of biochemical/biophysical characterization methods for vaccines or other biomolecules is required.
- Expertise in the development and implementation of mass spectrometry (Q-TOF and triple quadrupole) based assays (e.g. protein identification by database search tools, post-translational modification, protein or small molecule quantitation by MRM/AQUA) is required.
- Expertise in Agilent 6500 series Q-TOF, Waters Xevo TQS and Synapt, Thermo Q-Exactive, and Agilent and/or Waters HPLC systems is highly desirable.
- Expertise in reversed-phase and HILIC chromatography and CE is highly desirable.
- Experience in protein sample preparation/cleanup and dealing with matrix effect is highly desirable.
- Proven supervisory/leadership, verbal and written communication, organizational, networking and team skills.
- Experience in maintaining laboratories and equipment in cGMP compliance is an asset.
- Familiarity in analytical instrument qualification/validation is an asset.
- Expertise in one or more of the following technologies is an asset: SDS-PAGE, spectroscopy (e.g. CD, FTIR, UV), particulate analysis (e.g. DLS, MFI, AUC), calorimetry.
Location: Sanofi Pasteur – Toronto, Ontario Canada
Hours of Work:
Monday to Friday: 8:00 – 4:00 p.m.
Sanofi in Canada embraces diversity in the workplace and is committed to achieving employment equity. 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 applications from women, members of visible minorities, Aboriginal peoples and persons with disabilities.
Thank you in advance for your interest.
Only those candidates selected for interviews will be contacted.
We are an equal opportunity employer
Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.
At Sanofi, our ambition is to be an integrated global healthcare company, focused on patients’ needs. Much more than just a leading pharmaceutical company, Sanofi is committed to transforming scientific innovations into solutions and services that protect health, enhance life, and respond to the needs of the 7 billion people in the world. We trust our ambition to guide and inspire us as we work to create a future with optimal health and wellness for everyone.