Technologist Downstream

Sanofi; Toronto; On-site; CAD 66,000 - 68,000; Full time

Benefits offered by this job

Pay rate 48.02 CAD/hour

Job summary

Sanofi in Toronto is seeking a Technologist Downstream for a fixed-term contract to execute downstream processing, sterile filtration, and related QC testing. The role requires a strong background in biochemistry/microbiology and hands-on work in cleanrooms under cGMP guidelines.

You will train staff, participate in validation activities, and help maintain equipment, facilities, and documentation to support drug substance manufacturing.

Qualifications

• Education: College Diploma in a relevant scientific field with 12 months of experience.
• Preferred: Bachelor's degree with 12 months of experience in downstream processing or related field.

Responsibilities

• Execute downstream processing including sterile filtration and centrifugation.
• Set up and maintain equipment; perform CIP/COP and validation protocols.
• Perform sampling, testing, and environmental monitoring.
• Maintain cleanrooms and inventory; ensure cGMP compliance and inspection readiness.
• Prepare and revise SOPs, batch records, and change controls.

Skills

Purification Process

Production Equipment

Aseptic Technique

cGMPs

Chemistry

Microbiology

Biochemistry

Mathematics

Computer

Mechanical Aptitude

Technical Writing

Quality & Improvement

Safety

Education

College Diploma (Biochemistry, Microbiology, Bioengineering, Biotechnology, Chemistry, Chemical Engineering, Pharmaceutical Sciences)

Bachelor's degree (Biochemistry, Microbiology, Bioengineering, Biotechnology, Chemistry, Chemical Engineering, Pharmaceutical Sciences)

Tools

Training & Validation Tools

Job description

Reference no: R2868513 Position title: Technologist Downstream Duration: Fixed Term Contract - 11.5 months Location: Toronto, ON

About the Job

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

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. About Sanofi We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main Responsibilities

• 1. Execute downstream processing, sterile filtration of drug substance Set up, maintain a variety of automated and manually operated equipment and perform production activities in downstream processes: clarification by centrifugation and TFF, purification by zonal centrifugation, splitting by continuous flow centrifugation, inactivation, diafiltration and sterile filtration of drug substance. Perform troubleshooting and assessment of processes and technical problems. Clean-in-place (CIP), cleaning-out-of-place (COP) of downstream equipment and vessels. Provide training to personnel. Execute and verify IQ/OQ/PQ validation and cleaning verification protocols. Ensure all equipment, instruments and systems are properly assembled, installed, tested and maintained. Participate in preventive maintenance of production equipment and instruments.
• 2. Perform sampling and analytical tests - utility sampling, environmental monitoring and area-specific testing Sample processed materials and perform in-process testing according to procedures. Deliver samples to other departments on site as required. Perform area-specific testing, utility sampling and environmental monitoring for production.
• 3. Maintenance of Clean rooms, Equipment, Inspection readiness Perform routine cleaning and disinfection activities in classified environments. Maintain and organize cleanroom in good cGMP state and ensure area is always inspection ready. Submit equipment/material orders and maintain inventory of spare parts, purchased materials for downstream processing. Maintain safe and clean work environment by following site procedures and cGMP regulations. Participate in facility preparation and inspection readiness, safety and process audits.
• 4. Administration of data for drug substance operations Document, review and maintain production and monitoring activities for drug substance manufacturing. Draft, review and revise cGMP documents (SOPs/SWs, batch records, protocols, change controls, reports and other manufacturing supporting documents). Analyze, enter & verify data on paper based or electronic documents. Follow all SWls/SOPs and comply to site policies and procedures.
• 5. Participate in continuous process and equipment improvement, Health, Safety & Environment. Quality, and Inspection readiness initiatives Perform and participate in continuous improvement and development projects. Support Deviations, CCR, CAPA in Quality system as needed and assist until completion as per committed due dates. Participate in deviation investigations and root cause analysis. Follow HSE SOPs, identify and minimize risks, promote safety culture. Comply with HSE guidelines on the disposal of waste. No employee has a proprietary right to an activity or group of activities. Activities may be changed or reassigned to meet the needs of the operations.

About You

Minimum Qualifications:

• Education: Minimum 3 years College Diploma (Biochemistry, Microbiology, Bioengineering, Biotechnology, Chemistry, Chemical Engineering, Pharmaceutical Sciences), plus a minimum of 12 months of previous relevant work experience. Preferred 4 years Bachelor's degree (Biochemistry, Microbiology, Bioengineering, Biotechnology, Chemistry, Chemical Engineering, Pharmaceutical Sciences), plus a minimum of 12 months of previous relevant work experience.
• Skills and Knowledge: 1. Functional, Technical or scientific Purification Process. Production Equipment. Aseptic Technique. Current Good Manufacturing Practices (cGMPs). Knowledge and experience in Chemistry, Microbiology, Biochemistry. Mathematics, Computer, Mechanical Aptitude, Technical Writing, Quality and Improvement, Safety. 2. Supervisory, Managerial and Personal Communication I Networking Interpersonal / Teamwork Stress/Time Management Conflict Resolution Flexibility/ Adaptability Self-management Decision-making Creativity / Innovation Presentation Hours Of Work: Training: Inclusive from Monday to Friday 08:00 AM - 16:00 PM Shift Schedule: Inclusive from Sunday to Thursday/Tuesday to Saturday/ Friday to Tuesday 6:00 AM -14:00 PM (Subject to change). This is subject to change at any time and it should not be construed as limiting the right of the company to make such a change to meet the requirements of the operation.

Benefits and Perks

Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness program.

Equal Opportunity & Diversity

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.

Pay rate - 48.02 per hour

\"Artificial Intelligence" refers to any systems that use automated processes, including algorithms and machine learning, to analyze data and make predictions, inferences, decisions, or recommendations without direct human involvement. These systems may process personal information to identify patterns, improve services, or support decision-making. The Company may use Artificial Intelligence for purposes including, but not limited to, resume screening and hiring, scheduling interviews or meetings, conducting surveys, matching skills with potential job openings, interview scoring, ensuring compliance with regulations applicable to our industry, and activities related to performance evaluation. Information collected and processed by the Company’s Artificial Intelligence systems may include the personal information detailed above and calendar availability. It excludes the information collected and processed for monitoring purposes. You should contact Human Resources if you have a question or concern regarding your personal information. You can also contact Canada’s Privacy Officer via Sanofi’s data subject request portal,Data Subject Rights Webform. TheData Subject Rights Webformcan also be used torequest access or correction of your personal information and file a complaint.