Reference No. R2742391
Position Title: Microbiology Scientist - Vaccines
Department: Pharmaceutical Testing
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.
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Position Summary:
The Microbiology Scientist of Analytical Excellence is primarily responsible for ensuring the validated state of QC microbiology test methods, incorporating a life-cycle methodology for test method assessment, protocol design and execution, and coordination of all associated laboratory activities. The incumbent will ensure test method accuracy through review of control charts and conduct scientific investigations into causes of aberrant test results. The individual is also responsible for providing oversight and support to test transfers into and out of QC and for enabling the introduction of new technologies into QC.
Key Responsibilities:
- To design and manage validation of test methods used for licensed products, to maintain validated status throughout test method life-cycle, ensuring objectives and timelines are met (20%)
- To identify test performance issue and troubleshoot the problems, provide solution for test improvement. (20%)
- To support scientific investigations into causes of atypical or OOS test results. (20%)
- Supervise, train, motivate, empower and develop laboratory technical staff to ensure tasks are scheduled and completed according to project timelines (10%)
- To co-ordinate and manage test method transfers and introduction of new technologies ensuring objectives and timelines are met (15%).
- To communicate with Regulatory Affair regarding submission for test method changes or replacement. Provide response to regulatory agency's questions or requests (10%)
- To act as SME for microbiology test methods during inspection from Regulatory Agencies (5%).
HSE Requirement/Statement:
- Works within the policies, procedures and regulations as required by the Company and under the Occupational Health and Safety Act.
Context of the job/Major challenges:
- Management of multiple projects at any time.
- Unscheduled investigations which require support to resolve.
- Appropriate planning of project with multiple support functions to ensure completion by timeline.
Dimensions/Scope:
- Responsible to prepare budget for activities of approximately 3 FTEs and recommend capital equipment expenditure of up to $250K Canadian
- The incumbent will need to participate in interview and selection of candidates for junior departmental positions and will have supervisory responsibility for 3-5 subordinate professional or bargaining unit staff (technologists). He or she will provide guidance/indirect supervision to Managers and numerous technologists in other QO depts.
- Key decisions
- Quality compliance of release tests
- Validation designs
- Test method improvement requirements
- Quality compliance of release tests
Key Requirements:
- Preferably, M.Sc. or Ph.D. in Microbiology or equivalent with at least 5 years of related work experience in QC or a research setting. Alternatively, B.Sc. in Microbiology or equivalent with at least 10 years of related work experience in QC or a research setting.
- Specific experience in the development and verification/validation of microbiological methods for biomolecules/vaccines.
- Familiar with a broad range of analytical instrumentation in a cGMP/GLP compliant or highly regulated environment.
- Proven supervisory/leadership, verbal and written communication, organizational, critical thinking.
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 ourALL IN videoand check out our Diversity, Equity and Inclusion actions atsanofi.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
#GD-SP #LI-SP
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.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!