Reference Number: R2857977
Position title: B100 DT Upstream Technologist
Duration: Fixed Term Contract - 3 years
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'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.
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.
Execution of Upstream activities of drug substance
Assist in review of Records, SOP, and logbooks for completion and ensure accuracy of all documents as per GMP guidelines.
Participate in daily meetings and report findings to management.
Participate in deviation investigations and root cause analysis.
Coordinate with units within department (MWS, Upstream and Downstream)
Provide training to personnel.
Participate in IQ/OQ/PQ validation and cleaning verification protocols.
Ensure all equipment, instruments and systems are properly assembled, installed, tested and maintained.
Preparation of inoculum, analytical testing, area monitoring (utility sampling, environmental monitoring), maintenance, material handling, warehouse
Perform activities and documentation involved in Upstream including, in buffer preparation, inoculation preparation, fermentation, harvest, FIM antigen related processing and material handling using MES/PCS system.
Perform production calculations, measurements, and release checks. Ensure each cleaning meets standards set in SOP, records, and in accordance with GMP.
Observe in detail and report any process deficiencies, perform visual inspection of equipment for impurity and damage before and after cleaning.
Perform utility sampling and environmental monitoring as required and ensure the completion as adhered to schedule.
Ensure area is inspection ready.
Administration of data for drug substance operations and preparation of trending reports for SPC analysis
Document, review production and monitoring activities for cP & DT drug substance manufacturing
Complete SAP transactions in a timely, accurate manner.
Draft, review and revise various cGMP documents (SOPs/SWls, batch records, protocols, change controls, reports and other manufacturing supporting documents).
Analyze, enter & verify data on paper based or electronic documents.
Health, Safety and Environment and maintenance of GMP environment
Participate in keeping the production area and office areas in a tidy, GMP manner, following SS guideline or equivalent and supply materials as required
Disinfect area as required in SOP.
Assist to ensure loading dock and hallways are clean and unobstructed by materials or equipment, garbage is discarded daily to designated area outside production.
Use proper PPE when performing tasks.
Follow HSE SOP's, identify and minimize risks, promote safety culture.
Ensure chemicals are stored as per HSE requirement and has SDS available.
Participate in process improvement and equipment improvement, and Quality and Inspection readiness initiatives.
Assist implementation of facility, equipment, and process improvement projects
Assist in writing specifications, protocols and reports related to facility, equipment, and process improvement of production process
Modification of SOPs and BPR's for new processes in accordance with change control policies
Perform activities involved in IQ, OQ, and PQ for new equipment Initiate Deviations, CCR, CAPA in Quality system as needed and assist until completion as per committed due dates
Collaborate with other departments for root cause analysis and assist with implementation of corrective actions
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.
Minimum (3) three years College diploma (Biochemistry, Microbiology, Bioengineering, Biotechnology, Chemistry, Chemical Engineering, Pharmaceutical Sciences, other Life Science, or equivalent) plus a minimum of (2) two years of previous relevant work experience.
Preferred (4) four years Bachelor's degree (Biochemistry, Microbiology, Bioengineering, Biotechnology, Chemistry, Chemical Engineering, Pharmaceutical Sciences, other Life Science, or equivalent) plus a minimum of 18 months of previous relevant work experience.
Fermentation Process for cP bacteria, 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
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.
Mandatory Application Requirement: Your Workday application form must be complete, and a copy of your resume MUST be attached in the Workday application form, at the time you submit your Workday application, otherwise your application will not be considered for this position
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Applications received after the official close date will be reviewed on an individual basis.
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. The Data Subject Rights Webform can also be used to request access or correction of your personal information and file a complaint.
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.
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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Toute compensation sera déterminée en fonction de l'expérience démontrée. Les employés peuvent être admissibles à participer aux programmes d'avantages sociaux de l'entreprise. Des informations supplémentaires sur les avantages sociaux peuvent être trouvées ici.
