Scientist, Virology and Microbiology - Toronto, Ontario

Job description

Position Title : Scientist, Virology and Microbiology

Department: ARD Analytical Research & Development Canada/North America

Location: Toronto, Ontario

Summary of Purpose/Major Responsibilities:

·  Applies scientific expertise to select appropriate assays for the characterization and quality control of vaccines and other products to support the manufacturing processes.
·  Develops test methods for use as release, stability, and/or characterization assays for new and licensed vaccine products.  Test method development encompasses literature search, feasibility assessment, assay optimization, and validation.
·  Implements and maintains GxP compliant laboratories, instruments and testing programs where required.  Keeps abreast of relevant quality, regulatory, and GxP environments.
·  Fulfill the GLP Principal Investigator/Responsible Scientist /Study Director responsibility, as required.
·  Manages and develops competencies of direct reports to ensure compliance with GxP. Coaches and motivates staff to perform efficiently and achieve objectives on time and on budget. Promotes communication and good teamwork to ensure flexibility in the work place, and to support the completion of the objectives in ARD.
·  Provides scientific leadership for data interpretation, analysis and suitability of test methods. 
·  Designs and implements test method transfer protocols to receive and transfer assays to/from external and internal laboratories.  
·  Keeps abreast of relevant technology development and introduce new technologies into the Platform.
·  Supervises and monitors compliance with employment and health & safety legislation to ensure that employees work within the policies, procedures and regulations. 
·  Responsible for all people resources within the scope of their activity :
·  Manages their direct reports, and through them, others in their department or functional area to achieve high levels of employee commitment, productivity and retention.
·  Sets and monitors individual objectives, conducts annual performance appraisal, annual career development assessment with recommendations for technical and professional training, and periodic update sessions with reports to ensure performance, competencies and skills are aligned with expectations and company goals.  
·  Cascades relevant departmental, functional and organizational messages and is sensitive to our commitment to employment equity and our duty to accommodate.

Key Accountabilities:

Test Method Development:  

·  Develop new or improved test methods for new and licensed vaccine entity 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 GxP compliance, where required, in all testing programs. 
·  Review and approve test method technical reports.

Test Method Validation:  

·  Validate analytical test methods in support of release and stability testing. 
·  Design and lead the validation strategy and review and approve validation protocols.   
·  Present results to Project Team, platform director or regulatory agencies upon request. 
·  Review and approve validation reports.

Test Method Transfer:  

·  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 transfer reports.

Project support:

·  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 key regulatory documents, position/strategy papers as required.

Scientific Expertise:  

·  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.

Supervision:  

·  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 and execution of tests to support release of clinical lots and product characterization following GLP and GMP requirements.
·  Health and safety legislation support include the following:
·  Take every reasonable precaution to ensure the health and safety  of staff by ensuring that protective equipment and clothing required is used by staff and advises staff of any or potential or actual health and safety hazard of which they are aware.
·  Respond promptly to all health and safety concerns or incidents and complete the appropriate documentation in a timely manner. Ensure that incidents and work related illnesses are investigated and reported to the appropriate authorities.
·  Ensure all staff are trained and aware of their responsibilities with respect to compliance.

Education and Experience:

·  Ph.D. in Microbiology, Molecular Biology, Virology, Biochemistry or Immunology (as appropriate) with a minimum of 2-4 years relevant experience preferred or MS Degree with a minimum of 4-6 years relevant work experience. 
·  Specific experience in the development of new virological, microbiological,  biochemical and immunochemical characterization methods for biomolecules/vaccines. Familiar with a broad range of analytical instrumentation. 
·  Experience in maintaining laboratories and equipment in cGMP and/or GLP compliance. Familiarity with testing in compliance with current regulations is preferred.
·  Proven supervisory/leadership, verbal and written communication, organizational and team skills are required.

Sanofi Pasteur: The world’s leading vaccine company

Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines. Our driving goal is to protect people from infectious diseases by creating safe and effective vaccines.  Our company distributes more than 1 billion doses of vaccine each year, making it possible to vaccinate more than 500 million people across the globe.  Sanofi Pasteur offers the broadest range of vaccines in the world, providing protection against 20 bacterial and viral diseases.

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.  With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to a ttract, 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.

Sanofi, Empowering Life

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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.