B100 DT Upstream Technologist

Reference Number:R2857977

Position title: B100 DT Upstream Technologist

Duration:Fixed Term Contract - 3 years

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'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 ourcutting-edgescience and manufacturing,fueledby 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’rean 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:

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

AI Usage

"Artificial Intelligence” refers to any systems that use automated processes, including algorithms and machine learning, toanalyzedata and make predictions, inferences, decisions, or recommendations without direct human involvement. These systems may process personal information toidentifypatterns, 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 concernregardingyour personal information. You can also contact Canada’s Privacy Officer via Sanofi’s data subject request portal,  Data Subject Rights Webform.TheData 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 andretainhighly talentedemployees from diverse backgrounds, allowing us tobenefitfrom a wide variety of experiences and perspectives. We welcome and encourageapplications from all qualified applicants.  Accommodations for persons with disabilitiesrequiredduring the recruitment process are available upon request. 

Thank you in advance for your interest.

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