Reference No. R2730165

　　Position Title: Downstream Scientist

　　Duration: Fixed-Term - Contract End Date: December 6, 2024

　　Department: VDSD NA

　　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.

　　Position Summary:

　　Sanofi is accepting applications for a Downstream Scientist to join our Global Bioprocess Development (GBD) department. Reporting to the Platform leader or Unit Head, the Downstream Scientist will be responsible for the development of purification processes for the generation of clinical trials material (recombinant proteins) from microbial culture for use as vaccines. The scientist will interface between Analytical Sciences, and Manufacturing Science and Technology, and is accountable to fulfill the specific scientific, technical and compliance-related roles for assigned projects as defined by the GBD Leadership Team. The scientist will perform and work together with other team members to execute the experimental and processing tasks.

　　Key Responsibilities:

　　Responsible for specific scientific, technical and compliance aspects of assigned project, ensure that objectives are met. Plan and supervise execution of product development activities (develop, improve, scale-up processes, and provide material and documentation for purified proteins) within platform for the project to ensure scientific and technical excellence. Perform and work together with other team members to execute the experimental and process tasks.

　　To ensure good scientific and technical leadership within GBD and the platform, keep abreast of the current developments in relevant scientific and technical disciplines and ensure current developments are implemented when appropriate.

　　Prepare internal and external presentations, patent filings, research manuscripts and review articles as required.

　　Ensure compliance with GxP and other quality and documentation requirements, such as preparation of SOPs and BPRs. Provide leadership for data input, standardized formats, database creation and management, and implementation of corporate standards. Ensure following the current policies, new directions and training initiatives. Ensure teamwork and perform tasks efficiently and achieve objectives on time, on budget.

　　Share information and harmonize development within platform and department, and other departments such as Research, Analytical Sciences, Manufacturing Science and Technology, Manufacturing and Supply, R&D Quality, Regulatory Affairs, Clinical/Medical as necessary. Ensure good teamwork and provide high quality deliverables, such as technical reports, development reports within agreed timeframes. Support regulatory submission by participating in preparation of regulatory submission documents (CTA, IND, CTD).

　　In depth knowledge of experimental work and data analysis. Working knowledge of computer skills, scientific writing and presentations, communication skills, innovative thinking, and a familiarity with strategic planning, balanced judgment and risk analysis are required.

　　Works with the policies, procedures and regulations as required by the Company and under Occupational Health and Safety Act. Comply with employment and health and safety legislation to ensure work within the policies, procedures and regulations.

　　Platform Specific Accountabilities:

　　Development of purification processes for vaccine candidate supply. The process scale could arrange from 2L bioreactor scale to 200L bioreactor scale, and the purification process developed with targeted quality, yield and scalability requirement. The purification development needs to be transferable to clinical manufacturing platform for clinical trial material production. Expertise required includes various chromatography separation, buffer exchange and tangential flow filtration, centrifugation, sonication, protein stabilization during the purification process and chemical treatment as required.

　　Use of analytical methods for measuring purity, quality and process yield by assays such as protein content, SDS-PAGE, ELISA, HPLC, LAL et al. Development of appropriate in-process testing for the purification process development as needed.

　　Support for GMP manufacturing including process technology transfer, equipment selection and validation, process flows, vendor and raw materials selection, and process trouble shooting, as needed.

　　Key Requirements:

　　Minimal MSc (Biochemistry, Biochemical Engineering, Microbiology, Chemistry) with 2+ years’ experience, in protein purification, or vaccine development or relevant field.

　　In-depth knowledge of protein purification, primary recovery processes, process analytical technology and quality by design.

　　Hands on experience with HTPD to develop purification process, for example using Tecan.

　　Working knowledge of microbiology, biochemistry, chemical engineering principles.

　　Experience working in Upstream process and middle-stream process for recombinant protein production are assets.

　　In-depth knowledge of experimental design, execution and data analysis.

　　Strong computer, scientific writing and presentations skills.

　　Highly organized and excellent communication, interpersonal and working well within a team.

　　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.

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　　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.

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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.