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Technologist

SANOFI

This is a Contract position in Toronto, ON posted May 6, 2018.

TECHNOLOGIST (8 MONTH EMPLOYMENT OPPORTUNITY) Reference: R2454448 Location: Sanofi Pasteur Limited / North York, Ontario Address: 1755 Steeles Ave W, North York, ON M2R 3T4 Department: BioProcess R&D Required Education: University Degree (Biochemistry, Chemistry, Microbiology) or Masters Degree Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines.

For over 100 years, weve provided life-saving vaccines 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. We are home to Sanofi Pasteur’s North American centre for Analytical and Bioprocess R&D. As well, we are the largest Canadian vaccine producer: each year, we manufacture 50 million doses of vaccine and distribute them to more than 90 countries around the world, helping to protect against 20 infectious diseases. This variety of activities offers employees diverse opportunities for personal and professional growth. Our company attracts some of the best minds in the business from across the globe. Our 1,300 employees give us their best and we offer the best in return. Sanofi Pasteur Limited is looking for motivated and results driven individuals to join our R&D Department as a Technologist. Key responsibilities will include the following: Position Summary: 1. Participate and support the development , transfer and/or implementation of new technologist/equipment/process for formulation, filling and/or freeze-drying, which may be transferred locally from the Formulation and Stability Platform into the CSU or originate from within the CSU. Occasionally may also support the CSU Manager in the transfer of processes to other Sanofi sites or externally. Support BioProcess R&D and CSU with implementation of new equipment, as well as process development, tech transfer, implementation and/or optimization initiatives related to formulation, filling, lyophilization and visual inspection activities. Assist with documentation such as writing of SOPs and BPRs for new processes. Assist with shipping documentation and preparation of material for shipment to other sites or external collaborators. Assists with the training of technical personnel on new equipment, process and technologies to improve process efficiency and quality. 2. Support Formulation, Filling and Visual inspection GMP activities in Level 1 facility. This includes use of aseptic processing equipment including isolators, vial filling apparatus, and autoclaves. This also includes understanding and performance of environmental monitoring within the isolators and the surrounding Class C areas, as well as maintaining records for inventory of materials. Perform vial washing, isolator cleaning/set-up, VHP sterilization of isolators and associated equipment, glove integrity testing, HVAC recovery, operate the various equipment involved in the Formulation and Filling of clinical trial products, etc. Participate in aseptic formulation and filling of clinical products Perform visual inspection of vials Perform sampling and sample labeling of test/stability samples Maintain material/component stocks and clinical material inventory (physical counts, inventory logbooks, and SAP), order materials as necessary for clinical material production. Assist with internal and external quality audits, deviation investigations, root cause analysis, and the generation of corrective and preventative actions. 3. Support Label and Pack activities performed in the CSU label and Packaging Suites. This includes the execution of label and pack activities in accordance to site procedures, and the use of label printers. This also includes maintaining records for inventory of materials: Participate in the Label and Packaging of Clinical Trial Material in accordance to site procedures and GMP regulations. Perform sampling and sample labeling of test items. Assist with the generation of test recipe and test labels. Support the maintenance of the Label and Pack Suite in accordance to site procedures and GMP regulations. Assist with internal and external quality audits, deviation investigations, root cause analysis and the generation of corrective and preventative actions. Maintain material/component stocks and clinical material inventory (physical counts, inventory logbooks and SAP), order materials as necessary for clinical material labeling and packaging. Assist in the development and maintenance of production recipes (SAP). Participate in the assessment and implementation of new equipment/software/processes to support label/pack operations. 4. Assist in the preparation of SOPs, BPRs, protocols, investigation of non-conformances and initiation of change controls. Author, review and revise BRD validation documents. Write, edit and review SOPs and BPRs in accordance to site procedures and GMP regulations. Assist with writing, review and execution of protocols in accordance to site procedures and GMP regulations. Participate in the investigation and writing of non-conformances, as well as the initiation of change controls. Prepare, review, and modify validation documents related to purchase and validation of process equipment (URS, FRS, DSS, validation protocols, task lists, bills of materials and summary reports). 5. Be in compliance with employment and health & safety legislation and work within the policies, procedures and regulations Take every reasonable precaution to ensure the health and safety for self and co-workers Use required protective equipment and clothing Report critical incidents and accidents to the appropriate authorities Participate in the investigation of incidents and work related illnesses Respond promptly to all health and safety concerns or incidents and complete the appropriate documentation in a timely manner. Cooperate and assist in the Joint Health and Safety Committee that is carrying out its functions Participate and contribute to the PASS objectives. 6. Participate as required on working group, task forces, teams, etc. for consistency across BRD/CSU Platforms (locally and globally) Attend meetings as required Represent CSU platform in the development of processes, actively participate in creation and execution of action plan. Feedback to CSU Platform members on activities of the working group. Education and Experience: Minimum University Degree (Biochemistry, Chemistry, Microbiology) or Masters Degree Minimum of one (1) year of previous relevant experience in a Biotechnology, Pharmaceutical company, or University Research Institution. Demonstrated ability to work independently and make quick decisions in accordance with SOPs and training. Basic computer skills and the ability to enter data accurately and in a timely manner. Must be proficient in Microsoft Excel Hours of Work: Monday to Friday 8:00a.m.-4:00p.m. 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. #LI-SP #GD-SP 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, Empowering Life

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