Jump to content

Sanofi

Members
  • Posts

    2
  • Joined

  • Last visited

    Never

Everything posted by Sanofi

    • Full Time
    • 0
    • 0
    Reference No. R2722187 Position Title: Technologist Duration: Fixed-Term Contract (February 5, 2024- February 5, 2027) Subject to change Department: Influenza Vaccine manufacturing, Downstream Processing 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. Major Activities of the Job: Execute downstream processing, sterile filtration of Influenza drug substance: Set up, maintain a variety of automated and manually operated equipment and perform production activities in downstream processes: centrifugation 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. Perform other duties as assigned by department management throughout all stages of drug substance manufacturing related to B200 operations (MWS, Upstream and Downstream processes). Ensure all equipment, instruments and systems are properly assembled, installed, tested and maintained. Participate in preventive maintenance of production equipment and instruments. 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. 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. Administration of data for Influenza drug substance operations: Document, review and maintain production and monitoring activities for Influenza drug substance manufacturing. Draft, review and revise cGMP documents (SOPs/SWIs, batch protocols, change controls, reports and other manufacturing supporting documents). Analyze, enter & verify data on paper based or electronic documents. Follow all SWI/SOPs and comply to site policies and procedures. Participate in continuous process and equipment improvement, Health, Safety & Environment, Quality, and Inspection readiness initiatives: Perform and participate in continuous improvement and development projects. Initiate 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. Minimum Qualifications: Minimum three (3) years College Diploma ( Biochemistry, Microbiology, Bioengineering, Biotechnology, Chemistry, Chemical Engineering, Pharmaceutical Sciences ) plus a minimum of one (1) year of previous relevant work experience. Preferred four (4) years Bachelor’s Degree ( Biochemistry, Microbiology, Bioengineering, Biotechnology, Chemistry, Chemical Engineering, Pharmaceutical Sciences ) plus a minimum of one (1) year of previous relevant work experience. Purification Process for viral proteins. Production Equipment. Aseptic Technique. Current Good Manufacturing Practices (cGMPs). Chemistry, Microbiology, Biochemistry, Mathematics. Computer. Mechanical Aptitude and Technical Writing. Communication / Networking. Interpersonal / Teamwork. Stress/Time Management and Conflict Resolution. Hours Of Work: Inclusive from Monday - Friday: 8:00 a.m.- 4:00 p.m. (Subject to change) 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. Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com! 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. Follow Sanofi on Twitter: @SanofiCanada and on LinkedIn: https://www.linkedin.com/company/sanofi #GD-SP #LI-SP 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.
    • Full Time
    • 0
    • 0
    Reference No. R2718666 Position Title: Manager Quality Control Microbiology - EM Testing Duration: Fixed-Term - Contract End Date: March 28, 2025 Department: Microbiology 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: The QC Microbiology Manager is responsible for the supervision of various testing activities within QC Microbiology department, in compliance with cGMP and Quality systems. Responsible for planning and scheduling to ensure efficient and effective microbiology testing of raw materials, in process & finished products, the site’s environmental and utility system monitoring programs, aseptic broth simulation studies and validation of sterilization processes. Responsible for the test approval following GMP and site SOPs. Maintain quality and compliance procedures of the QC Microbiology group. Act as Lead Investigator to coordinate and manage the investigation of non-conformance's from initiation to closure. Provide scientific support for changes to test methodologies/ equipment. Provide supervision, coaching and guidance to technical staff. Participate in hiring and other administrative activities for the department as required. Key Responsibilities: Supervise microbiological testing of samples such as raw materials, in process & finished products, the site’s environmental and utility system monitoring programs, aseptic broth simulation studies and validation of sterilization processes: Day-to-day organization and planning to ensure efficient and effective testing of samples and anticipate to surges of work load. Responsible for ensuring all testing materials, stock cultures and resources are planned, equipment and lab areas are maintained to support testing demands. Responsible for review and approval of testing records and ensure documentations meet GMP, compendial and company standards procedures: Maintain quality and compliance procedures so that microbiology testing procedures and documentation all meet GMP and compendial standards, and staff are appropriately trained in relevant procedures. Responsible for review and approval of study protocols, data summaries, microbiological investigations and associated reports. Utilization and support of data management/release systems. Participate in internal and Regulatory audits. Responsible for maintaining departmental testing records ensuring all staff follow quality and compliance procedures: Train and motivate staff to perform required testing or activities. Provide coaching and guidance to direct reports. Responsible for maintenance of the lab training program and records. Responsible for administration activities and support hiring process of union staff, as required. Troubleshoot laboratory test problems, and develop and update laboratory procedures/instrumentation taking into consideration progressive facility or equipment improvements, efficiency enhancements and updates in regulations. Provide methods validation support for changes to test methodologies or test transfers. Act as Lead Investigator to coordinate and manage the investigation of non-conformances from initiation to closure to: Ensure all appropriate subject matter experts are involved and contribute to the investigation strategy. Liaise with their respective QO rep to provide a draft and final investigation report and supporting documentation. Identify root cause and ensure appropriate corrective/preventative actions are implemented. Review and approval final investigation report. Responsible for implementation and adherence of all safety procedure and guidelines to ensure a safe working environment is maintained: Ensure training of staff on relevant safety procedures. Ensure safety audit are carried out on a monthly basis and that deficiencies are reported and corrected in a timely fashion. Responsible for hosting and addressing to Joint Health and Safety Audits in a timely fashion. Ensure safety data sheets (SDS) are current and available. Communication of technical information/ data updates to Sterility Assurance, manufacturing, Regulatory Affairs and R&D as required. Key Requirements: Qualifications include a degree (B.Sc. or M.Sc, preferred) in Microbiology or closely-related discipline, plus a minimum of five (5) years relevant experience in an Industrial Microbiology laboratory with a high volume, rapid turnaround sample throughout. In depth knowledge of QC microbiology techniques and compendial standards including but not limited to sterility, bioburden, endotoxin, environmental monitoring, microbial identification, and growth promotion. Strong technical and scientific leadership to ensure GMP compliance. Strong understanding of Pharmacopeia. Experience managing a team. Knowledge of analytical method development, test transfer, and method validation. Knowledge of the failure investigation management system and change management system. Good knowledge of GMP requirements and experience with regulatory audits. Experience in leading projects/teams. Strong interpersonal and communication skills combined with solid problem solving and organizational skills. Solid computer and technical writing skills. A team player with demonstrated leadership and supervisory abilities. 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. Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com! 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. Follow Sanofi on Twitter: @SanofiCanada and on LinkedIn: https://www.linkedin.com/company/sanofi #GD-SP #LI-SP 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.
    • Full Time
    • 0
    • 0
    Reference No. R2720259 Position Title: Water system senior Technologist Duration: Fixed-Term - Contract, End Date: December 27, 2024 Department: Critical Utilities & Support 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. Major Activities of the Job: Operate and maintain critical utilities including but not limited to purified water (PW), clean steam (CS) and water for injection (WFI) generation, storage and distribution systems in accordance with established SOPs and SWIs in a professional and timely fashion and initiate any required repairs and rechecks. Actively operate and troubleshoot the Delta V operating systems for critical utility systems in accordance with critical utility system SOPs. Troubleshooting and repair of each buildings critical utilities systems and equipment specific to purified water (PW), clean steam (CS) and water for injection (WFI) generation, storage and distribution systems. Ensure 24 hours/7 days, uninterrupted, continuous operation of PW, WFI and CS generation, storage and distribution systems. Coordinates and works with other trades, engineering, contractors and stores to ensure maintenance work is completed in a timely fashion. Perform repairs where a specialized license is not required. Examples include diaphragms, tri-clamps, hoses, pumps, filters, membranes and gaskets replacements. Use P&IDs and manuals as required for troubleshooting. Provide update on issues to manager, quality (QOSA or Shop Floor) and internal customers as required and timely release of the critical utility systems during PM shutdowns. Execute or follow-up on reactive, preventative, and predictive maintenance tasks as assigned on cGMP critical utilities in accordance with established effective SOPs. Supervise contractors performing PM tasks on cGMP critical utilities. Carry out preventative and predictive maintenance tasks based on established daily, weekly, monthly, annual frequencies using SAP work order system where not restricted by regulatory licensing requirements. Prepare and initiate utility assessment documentation for all critical utility shutdowns and restarts. Identify, request and register parts when required to perform reactive or routine maintenance. Ensure proper equipment lock out and tag out procedures are executed as required. Administer the release of critical utilities for production use (i.e timely review of all applicable data to ensure compliance to established standards and requirements). Supervise contractors performing maintenance tasks on the critical utilities such as passivation, calibration, etc. Monitor mechanical rooms for cleanliness and any other abnormal conditions such as leaks, and carryout repairs as required. Determines impact of required work, communicates, co-ordinates and perform major PM cGMP tasks such as RO/CDI maintenance, critical utility cleaning / passivation / steam sanitization maintenance tasks. Routine quality monitoring of PW Generation and Distribution Systems, WFI Generation and Distribution Systems and Clean Steam Generation and Distribution System. Coordinate major PM tasks / shutdown work on critical utilities with planning, internal customer, trades and contractors to minimize service interruption. Review major planned shutdown work orders with planner using the SAP system. Co-ordinates with stores to ensure all necessary parts such as vent filters, RO Membranes, Continuous Deionization stacks, rupture discs, UV lights, filters, etc. are available. Maintain and replace caustic and basophile chemicals, oil and salt levels. Monitors the condition of the metallic-product contact surfaces of the purified water, clean steam and water for injection generation, storage and distribution through trace metal analysis and visual inspection. Proactively initiates remediation through passivation of the systems and the corresponding steam sanitization of the critical utility systems. Arranges for shutdown work in coordination with planner and building managers. Performs vent filters, RO membranes, rupture discs, UV lights/sleeves, filters, CDI stacks replacement. Daily verification and logging of critical operational process measurement and control instrumentation parameters via approved log sheets. Recommend appropriate alert/action limits for routine monitoring. Perform utility data analysis. Review all relevant data on regular basis and recommend corrective/preventive actions and applicable product disposition. Make running adjustments to equipment within validated operational parameters. Monitor FMS / BAS / DMS/ PI / Delta V system for proper operation of critical utilities such as purified water (PW), clean steam (CS), water for injection (WFI) generation, storage and distribution systems. Respond or identify all cGMP and business critical alarms within the required time frame. Provide support for trouble shooting issues, addressing related N/Cs and / or CAPA / CCR related documents. Monitor FMS / BAS / DMS/ PI / Delta V systems for proper operation of equipment / systems. Respond to alarms and carry out necessary troubleshooting / repairs to resolve alarm conditions. Coordinate with other trades, engineering and contractors if needed to resolve any alarm issues. Inform the manager, quality (QOSA and/or Shop Floor) and internal customer of the troubleshooting, corrective and preventative actions taken / needed to correct alarm conditions. Update alarm tag notes in the system. Document information in the work order system. Initiating and leading CAPAs and CCRs. Support gap and/or process improvement assessment. Collect relevant data for investigation and analysis. Present findings and follow up on remedial/improvement actions. Participate, coordinate and provide support during audit and internal/external inspection. Prepare inspection readiness of the critical utility systems in a timely manner. Defend the critical utility systems monitoring program during internal and external inspection when required. Operate critical utilities such as purified water (PW), clean steam (CS) and water for injection (WFI) generation, storage and distribution systems in accordance with established SOPs and SWIs. Operate critical utilities such as purified water (PW), clean steam (CS) and water for injection (WFI) generation, storage and distribution systems in accordance with established SOPs and SWIs Troubleshoot and maintain critical utilities and associated systems. Document and log critical utility equipment and system conditions. Inform the manager, quality (QOSA and/or Shop Floor) and internal customer of the troubleshooting, corrective and preventative actions taken / needed to correct alarm conditions. Any other duties and responsibilities as assigned such as commissioning, qualification, and validation of new critical utility systems, training new water systems technologists / contractors, authoring and updating all operational critical utility SOPs, managing or leading relevant CAPAs & CCRs, assist on deviations / safety investigations, initiating work orders. Other activities as requested which may include Continuous Improvement projects, initiatives or tasks. Develop and/or review critical utility systems related specifications, SOPs and SWIs. Train new water system technologists as required. Write and execute supplements for commissioning, qualification, and validation of new critical utility systems. Participate in design reviews and assist in writing new SOPs and PM Plans for new systems. Other duties as assigned to operate the business. Minimum Qualifications: Minimum three (3) years College Diploma (Controls, Instrumental, Mechanical Engineering, Mathematics, Science, Biology, Chemistry, Physics), plus a minimum of three (3) years of previous relevant work experience. Preferred four (4) years bachelor’s degree (Controls, Instrumental, Mechanical and Process Engineering), plus a minimum of three (3) years of previous relevant work experience. Other recognized formal education 1 week to 3 years of ÌSA, PDA Pharma certificate or Credit Programs (Hydraulic, Electrical / Electronic, Pneumatic Measurement & Control Principles, PLC, SCADA, DCS programming, Pharmaceutical / Life Science Courses). Strong knowledge of Process management and controls. Strong knowledge of Blueprint reading and Red Lining And Technical Writing & Documentation. Microbiology, DI/RO /continuous Electronic Deionization. Hours Of Work: Inclusive from Monday to Friday: 8:00 A.M – 4:00 P.M. 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. Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at www.sanofi.com ! 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. Follow Sanofi on Twitter: @SanofiCanada and on LinkedIn: https://www.linkedin.com/company/sanofi #GD-SP #LI-SP 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.
    • Full Time
    • 0
    • 0
    Reference No. R2722405 Position Title: Packaging Technician Department: Filling & Packaging Night Shift Duration: Fixed-Term - Contract, End Date: December 20, 2024 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. Major Activities of the Job: Monitor all tasks in packaging areas: Member of a team in packaging accomplishing all tasks involved in completion of assigned work orders. Examine (manual & Seidenader) running capper operation. Filling in B.P.R.'s. Maintain equipment in a good condition: Report unusual sounds, smells etc. Clean machines, change webbing, set up scales (minor mechanical), record computer data entry (or other software) for measurement of line performance index. Troubleshoot environmental monitoring equipment & take appropriate action to protect product & safety. Plan for training: Attend team meetings. Plan training. Organization of an operation including assigning people within the operation, timing of activities, ongoing planning of relief, identifying the need for assistance or overtime to maintain production. Ensure quality of the packaging process: cGMP training, Health & Safety, gowning for packaging, SOP training, documentation training. Learn to operate basic labeling & packaging machines safely. Basic sign in on BPR, retrieve & check components to BPR. Provide training: Training on all required equipment & documentation & activities to be able to fulfill this level's requirements under the direction of Group Leader, & training specialist. Train new members. Minimum Qualifications: Minimum two (2) years College Diploma (Pharmaceutical Technology), plus a minimum of twelve (12) months of previous relevant work experience. Preferred three (3) years College Diploma (Pharmaceutical Technology), plus a minimum of six (6) months of previous relevant work experience. Mechanical CGMP, Health & Safety Mathematics, weights & measures Process knowledge Computer Problem solving Communication Interpersonal skills Hours Of Work: Inclusive from Monday to Friday at 23:00 - 07:00 (shift starts at Sunday 23:00) 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. Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com! 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. Follow Sanofi on Twitter: @SanofiCanada and on LinkedIn: https://www.linkedin.com/company/sanofi #GD-SP #LI-SP 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.
    • Full Time
    • 0
    • 0
    Reference No. R2722406 Position Title: Packaging Technician Department: Filling & Packaging Night Shift Duration: Fixed-Term - Contract, End Date: December 20, 2024 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. Major Activities of the Job: Monitor all tasks in packaging areas: Member of a team in packaging accomplishing all tasks involved in completion of assigned work orders. Examine (manual & Seidenader) running capper operation. Filling in B.P.R.'s. Maintain equipment in a good condition: Report unusual sounds, smells etc. Clean machines, change webbing, set up scales (minor mechanical), record computer data entry (or other software) for measurement of line performance index. Troubleshoot environmental monitoring equipment & take appropriate action to protect product & safety. Plan for training: Attend team meetings. Plan training. Organization of an operation including assigning people within the operation, timing of activities, ongoing planning of relief, identifying the need for assistance or overtime to maintain production. Ensure quality of the packaging process: cGMP training, Health & Safety, gowning for packaging, SOP training, documentation training. Learn to operate basic labeling & packaging machines safely. Basic sign in on BPR, retrieve & check components to BPR. Provide training: Training on all required equipment & documentation & activities to be able to fulfill this level's requirements under the direction of Group Leader, & training specialist. Train new members. Minimum Qualifications: Minimum two (2) years College Diploma (Pharmaceutical Technology), plus a minimum of twelve (12) months of previous relevant work experience. Preferred three (3) years College Diploma (Pharmaceutical Technology), plus a minimum of six (6) months of previous relevant work experience. Mechanical CGMP, Health & Safety Mathematics, weights & measures Process knowledge Computer Problem solving Communication Interpersonal skills Hours Of Work: Inclusive from Monday to Friday at 23:00 - 07:00 (shift starts at Sunday 23:00) 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. Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com! 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. Follow Sanofi on Twitter: @SanofiCanada and on LinkedIn: https://www.linkedin.com/company/sanofi #GD-SP #LI-SP 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.
  1. Sanofi

    Technologist - Toronto, ON

    • Full Time
    • 0
    • 0
    Reference No. R2721672 Position Title: Technologist Duration: Fixed-Term - Contract End Date: December 20, 2024 Department: References & Critical Reagents 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. Major Activities of the Job: Coordinates and performs routine standard testing: Coordinates and performs Critical Reagent Qualification: Responsible for writing protocols and reports for test transfer and method validations. Executes testing including parallel testing and/or experiments, which may involve the improvement of standard tests performed in the department. Compiles data, performs preliminary statistical analysis and troubleshoots, if required. Co-ordination of testing schedules, as required. Updates all relevant documents as required, implements changes (e.g. SOP changes). Documentation – Testing and Support Documents: Responsible for the timely, accurate completion and review /verification of test related documents to ensure on time delivery oftest results (e.g. LIMS, worksheets, logbooks, NuGenesis templates, Statistical calculation programs, verification of calculations and document entries for accuracy). Responsible for photocopying and delivery of approved documents and for the organizing and management of documents in accordance with department and corporate policies (binding worksheets, filing, compiling documents for archival). Review existing SOPs and initiates revisions or writing of SOPs, protocols, reports and test summaries as required. (e.g. Qualification of test reagents, test transfers, test method validations). Responsible for ensuring SOP accuracy and timely updates, cascades changes to all staff affected by initiating SOP reviews. Ensures the accuracy of test documents and the timely update of worksheets and log sheets in the electronic worksheet management system as required. Responsible for updating and maintaining trending data as required. (e.g. Trending oftest controls, standards and products). Responsible for accurately compiling data for tests, products, trending for statistical reports, to support regulatory questions and / or submissions as required.​ Responsible for ensuring accuracy of critical reagent inventory as related to responsibility. Responsible for collection and preparation of data for regulatory submissions and inquiries. ​ Maintenance of Quality Systems including adherence to GXPs and safety guidelines: Ensures compliance is maintained in all daily activities by following SOPs (divisional, department and test), protocols and procedures as they apply. Reviews SOPs and documents training. Responsible for identifying and notifying Manager of any laboratory non- conformances or quality notification. Files laboratory investigation reports, non-conformances, and quality notifications as required, provides required support documentation to expedite closures of events. Participate in root cause analysis to identify appropriate corrective actions for CAPA and events. Act as Change Control Initiator or Leader as needed. Responsible for creating and reconciling controlled testing worksheets in the Electronic Document Management system. Provide weekly testing information for general metrics to Manager. Ensures adherence to GMP guidelines and attendance at regularly scheduled updates. Ensures adherence to safety guidelines as outlined in corporate and site policies. Responsible for reviewing MSDS sheets and ensuring compliance with requirements. Reports any major damages/abnormalities to Manager and/or notify Security/ Physical Plant, as well as initiate and follow-up on maintenance work orders. Maintains necessary immunization status up to date. Test Transfer, Validation, & Implementation: Responsible for writing protocols and reports for test transfer and method validations. Executes testing including parallel testing and/or experiments, which may involve the improvement of standard tests performed in the department. Compiles data and performs preliminary statistical analysis and troubleshoots, if required. Co-ordination of testing schedules, as required. Updates all relevant documents as required, implements changes (e.g. SOP changes). Participation in specialized projects I experiments/ continuous improvement of existing tests: Participates in special projects, experiments or assays as required for existing products and new products (e.g. collaborative studies with regulatory agencies and organizations on method comparison, assay harmonization, new assay development). Attends team meetings providing technical expertise and performs the respective assays as required. Performs trouble shooting I test modification and experiments as required. Coordination of testing schedule, as required. Compiling, analyzing, performing preliminary statistical analysis on all relevant results and conclusions. Responsible for writing protocols, reports and SOP as required. Training I skills upgrade I literature review: Complete on-the-job training according to current Lesson plans, and document as required. Attends and participates in relevant training sessions continuously. Review relevant SOPs / literatures continuously. Attends departmental weekly meetings. Participate in regularly scheduled GMP updates and safety training. Assists in training of new staff or existing personnel as required. Trains existing personnel in changes to new test methods once implemented. Performs literature searches to stay abreast of new technology. 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 Qualifications: Minimum four (4) years bachelor’s degree (Immunology, Cell Biology, Molecular Biology, Biochemistry) plus a minimum of (3) years of previous work experience. Preferred two (2) year master's degree (Chemistry, Biochemistry, Immunology, Biomedical Sciences or Molecular Biology), plus a minimum of 18 months of previous work experience. Standard and Advanced Immunological Techniques. Aseptic Techniques. Theoretical and Research related knowledge, Immunology, Biochemistry, Cell Biology, Virology. SAP I Network Systems Operation/ FMS /BAS SOP development. GMP/GLP. Computer knowledge hardware, software, interfaces (LIMS, NuGenesis, Basic troubleshooting). Mathematics / Statistics. Purification techniques. Accuracy, Organization, Judgment, Verbal and Written communication. In order to remain knowledgeable in the Immunology/ Immunochemistry/ Virology field, the analyst is required to keep up to date and upgrade skills as required on testing techniques, procedures and general Immunochemistry as well as to continue to improve and upgrade technical skills. Hours Of Work: Inclusive from Monday to Friday, 8:00 a.m. – 4:00 p.m. This is subject to change at any time and it should not be construed as limiting the right of the company to make such change to meet the requirements of the operation. 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. Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com! 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. Follow Sanofi on Twitter: @SanofiCanada and on LinkedIn: https://www.linkedin.com/company/sanofi #GD-SP #LI-SP 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.
    • Full Time
    • 0
    • 0
    Reference No. R2722846 Position Title: Operations Manager (Media, Washing, & Sterilizing) – New Influenza Antigen Manufacturing Building Duration: Fixed-Term - Contract End Date: February 7, 2025 Department: B200 Operations – Buffers, MWS & Logistics 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. Who You Are: You are a dynamic individual with a passion for public health. You believe in ensuring safe, high-quality vaccines are accessible to all, and thus you have a desire to join Sanofi at the Toronto site. You have a proven track record of delivering on project milestones to ensure the success of a key project within challenging timelines. The Team: The Media, Washing, & Sterilizing (MWS) Manager reports directly to the Deputy Director – Media, Washing, & Sterilizing for Flu Vaccine manufacturing. This is a rapidly growing team responsible for the technology transfer and start-up of a high-profile global project. Job Highlights: Participate in the design, commissioning, startup, and troubleshooting of MWS processes (Raw Material receipt/handling/storage, Weighing & Dispensing, Buffer Preparation, Decontamination, Washing & Sterilizing) and equipment operations through all stages of project (C&Q, IQ/OQ, Engineering and Consistency runs, full operations) Manage the procurement process and readiness of small equipment within Operations for engineering runs and start-up Review and approve technical and quality related documentation (P&ID, IOQ, PPQ, and design documents) Provide troubleshooting and problem-solving guidance for daily project and manufacturing issues, and implement preventative/corrective actions Participate and support the incorporation of digital technology (i.e., electronic batch record, electronic logbooks, process automation) into manufacturing process in the new facility to reduce costs and to improve quality and delivery capability Develop and execute production schedules from project through full scale manufacturing, ensuring that project support and production activities are executed as per defined schedules Lead operations team execution on the shop floor for equipment, processes, and facilities Monitor and communicate team and project performance with respect to deliverables using visible metrics Support development of operating budget and staffing for operations and project related activities from design to start-up In collaboration with the site Quality team, ensure compliance with GMP requirements, develop quality continuous improvement initiatives, and develop staff quality culture and GMP knowledge Ensure that all Operating Procedures, training plans, and manufacturing documentation are current, developed in adherence to global and site policies, and completed in a timely manner Support internal and external regulatory audits/inspections and coordinate appropriate responses Identify and lead initiatives to increase process efficiency, quality and/or yield. Implement solutions or changes via change control, plan and manage facility and organization improvements. Basic Qualifications: Bachelor of Science Degree in Engineering or Scientific Discipline, and 5+ years of industry experience in a GMP environment Preferred Qualifications: Experience managing direct staff in a GMP environment Highly proficient in Word, Excel and Powerpoint Experience with SAP (preferred) or other Enterprise Resource Planning (ERP) system Experienced with manufacturing automation (ex. DeltaV) and/or electronic batch records Ability to set priorities and act with appropriate sense of urgency Ability to collaborate with cross-functional peers, including change management, quality disciplines, and production management Ability to work quickly with a high degree of accuracy Sound interpersonal and information gathering skills The Fine Print: The position is based in Toronto and will involve occasional business travel to the US Sanofi site, as well as travel to other domestic/international equipment vendors. Work will be a blend of in-person and remote during early project phases, and 100% in-person thereafter. Current work hours will be on the Day Shift, but will transition permanently to Afternoon Shift when required based project/operational needs. 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. 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.
    • Full Time
    • 0
    • 0
    Reference No. R2722842 Position Title: Operations Manager (Media, Washing, & Sterilizing) – New Influenza Antigen Manufacturing Building Duration: Fixed-Term - Contract End Date: December 19, 2025 Department: B200 Operations – Buffers, MWS & Logistics 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. Who You Are: You are a dynamic individual with a passion for public health. You believe in ensuring safe, high-quality vaccines are accessible to all, and thus you have a desire to join Sanofi at the Toronto site. You have a proven track record of delivering on project milestones to ensure the success of a key project within challenging timelines. The Team: The Media, Washing, & Sterilizing (MWS) Manager reports directly to the Deputy Director – Media, Washing, & Sterilizing for Flu Vaccine manufacturing. This is a rapidly growing team responsible for the technology transfer and start-up of a high-profile global project. Job Highlights: Participate in the design, commissioning, startup, and troubleshooting of MWS processes (Raw Material receipt/handling/storage, Weighing & Dispensing, Buffer Preparation, Decontamination, Washing & Sterilizing) and equipment operations through all stages of project (C&Q, IQ/OQ, Engineering and Consistency runs, full operations) Manage the procurement process and readiness of small equipment within Operations for engineering runs and start-up Review and approve technical and quality related documentation (P&ID, IOQ, PPQ, and design documents) Provide troubleshooting and problem-solving guidance for daily project and manufacturing issues, and implement preventative/corrective actions Participate and support the incorporation of digital technology (i.e., electronic batch record, electronic logbooks, process automation) into manufacturing process in the new facility to reduce costs and to improve quality and delivery capability Develop and execute production schedules from project through full scale manufacturing, ensuring that project support and production activities are executed as per defined schedules Lead operations team execution on the shop floor for equipment, processes, and facilities Monitor and communicate team and project performance with respect to deliverables using visible metrics Support development of operating budget and staffing for operations and project related activities from design to start-up In collaboration with the site Quality team, ensure compliance with GMP requirements, develop quality continuous improvement initiatives, and develop staff quality culture and GMP knowledge Ensure that all Operating Procedures, training plans, and manufacturing documentation are current, developed in adherence to global and site policies, and completed in a timely manner Support internal and external regulatory audits/inspections and coordinate appropriate responses Identify and lead initiatives to increase process efficiency, quality and/or yield. Implement solutions or changes via change control, plan and manage facility and organization improvements. Supervises a team of 10-20 people in production and support activities throughout the progress of the project on the Afternoon Shift Basic Qualifications: Bachelor of Science Degree in Engineering or Scientific Discipline, and 5+ years of industry experience in a GMP environment Preferred Qualifications: Experience managing direct staff in a GMP environment Highly proficient in Word, Excel and Powerpoint Experience with SAP (preferred) or other Enterprise Resource Planning (ERP) system Experienced with manufacturing automation (ex. DeltaV) and/or electronic batch records Ability to set priorities and act with appropriate sense of urgency Ability to collaborate with cross-functional peers, including change management, quality disciplines, and production management Ability to work quickly with a high degree of accuracy Sound interpersonal and information gathering skills The Fine Print: The position is based in Toronto and will involve occasional business travel to the US Sanofi site, as well as travel to other domestic/international equipment vendors. Work will be a blend of in-person and remote during early project phases, and 100% in-person thereafter. Current work hours will be on the Day Shift, but will transition permanently to Afternoon Shift when required based project/operational needs. 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. 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.
    • Full Time
    • 0
    • 0
    Reference No. R2722399 Position Title: Data Access Management Specialist Department: Program Management Location: Downtown area of Toronto, Ontario 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. As one of Canada’s leading investors in life sciences, manufacturing and research and development, we focus on delivering new and better ways to address unmet medical needs. Our life-changing and lifesaving products are grounded in science that Canadians can trust. They empower self-care, prevent and treat diseases, and help people live better. Our vision for digital, data analytics and AI Sanofi has embarked into a vast and ambitious digital transformation program. A cornerstone of this roadmap is the acceleration of its data transformation and of the adoption of artificial intelligence (AI) and machine learning (ML) solutions. This has enabled us, to accelerate R&D, improve manufacturing and commercial performance, and bring novel drugs and vaccines to patients faster, all in order to improve health and save lives. The Digital Team at Sanofi is a unique data-driven team. We pride ourselves on being data obsessed and highly focused on using state of the art processes along with global technologies to drive impact to our solutions. We measure our insights and products based on how they perform across the globe and hold ourselves to the highest regard as our solutions can impact millions of lives. When tackling a problem, we do not just ask how we will create a solution, but how we will create a solution that reaches across the world with the best possible societal outcome. If you are passionate about improving the health and wellness of people across the globe using Data as your means, then you should look no farther than the Digital Team here at Sanofi. Join us on our journey in enabling Sanofi’s Digital Transformation through becoming an AI first organization. AI Factory - Versatile Teams Operating in Cross Functional Pods: Utilizing digital and data resources to develop AI products, bringing data management, AI and product development skills to products, programs and projects to create an agile, fulfilling and meaningful work environment. Leading Edge Tech Stack: Experience build products that will be deployed globally on a leading-edge tech stack. World Class Mentorship and Training: Working with renowned, published leaders and academics in machine learning to further develop your skillsets. Who You Are: The Data Access Management Specialist is responsible for ensuring the proper process and technology is implemented for controlling access to data assets within our organization. This role involves implementing and maintaining data access best practices and tools to ensure the right users have appropriate access to assets within our data mesh. You take pride knowing your work enables innovation and helping Sanofi build better solutions. Key Responsibilities: Participate in an agile team driving Data Access capabilities by helping to identify access requirements/restrictions, streamlining authorization processes and supporting major programs. Ensure data security and compliance with relevant data protection regulations (e.g., GDPR, HIPAA) by implementing access controls, encryption, and auditing mechanisms. Collaborate with the Business stakeholders, vendors, product owners and third-party service providers to ensure data access practices align with business objectives. Collaborate with Program Management team to update project/program plan, report risks/issues, discuss mitigation strategy, program status. Integrate with other solutions such as Data Catalog, Data Marketplace, data platforms like Snowflake and AWS, authentication solutions like Active Directory and enablement through ServiceNow. Help design, implement and maintain Data Access control frameworks such are Role Based Access Control (RBAC), Attribute Based Access Control (ABAC) and/or Policy Based Access Control (PBAC) in conjunction with classification and sensitivity of the data. Obtain and assess Data Access requirements and provide input to solution design and architecture to ensure the solution meets requirements. Perform exploratory Data Access analysis to support feature generation. Identify, analyze, interpret trends or patterns in Data Access issues and requests, arranging and driving deeper insights. Actively solicit stakeholder feedback on Data Access technical and functional capabilities and drive improvements as needed. Gather requirements needed to sustainably implement data management, data access and policy standards. Partner with various data team members to drive innovation. Partner with change management team to participate in change management strategic decisions. Help prepare regular updates for stakeholders regarding proposed solutions, timelines, progress, and issues. Participate in testing activities to ensure tool integrations are properly implemented. Evolve and enhance training content and capability web page for Data Access solution. Key Requirements: Bachelor’s degree in computer science, Information Technology, or a related field. Proven experience in data management, with a focus on Data Access control solutions. Knowledge of Data Cataloging, Data Marketplace, and Data Management tools (Such as Informatica Cloud Data Governance & Catalog (CDGC), Cloud Data Marketplace (CDMP, Cloud Data Integration (CDI)). Strong understanding of system/software development lifecycle and processes. Good understanding of cloud-based platform as a service and management and maintenance of cloud based secured trusted network infrastructure (e.g., AWS) required as the foundation for Data Access solutions. Good understanding of databases, data structures, and analytical solution structures (esp. Snowflake, AWS). Good understanding of encryption, masking, anonymization and pseudonymization. Experience with process design, implementation, and improvement Excellent written and verbal communication skills. Strong competency for working with business stakeholders, managing and meeting their demands. Attention to detail, sense of urgency, and commitment to deadlines Strong analytical skills with the ability to identify, quantify, and effectively raise business risks associated with data access. Experience developing best practices, policies, and/or procedures. Understanding of data protection, privacy laws and regulations. Exposure to tools used to support Data Access management, such as Immuta, Active Directory, ServiceNow, etc. Nice to have: Experience working in life sciences/pharmaceutical industry is a plus. Certification in data management tools is a plus. 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. Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com! 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. Follow Sanofi on Twitter: @SanofiCanada and on LinkedIn: https://www.linkedin.com/company/sanofi #DBBCA #DDB 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.
    • Full Time
    • 0
    • 0
    Reference No. R2722606 Position Title: Data Management Analyst - Data Quality Department: Program Management Location: Downtown area of Toronto, Ontario 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. As one of Canada’s leading investors in life sciences, manufacturing and research and development, we focus on delivering new and better ways to address unmet medical needs. Our life-changing and lifesaving products are grounded in science that Canadians can trust. They empower self-care, prevent and treat diseases, and help people live better. Our vision for digital, data analytics and AI Sanofi has embarked into a vast and ambitious digital transformation program. A cornerstone of this roadmap is the acceleration of its data transformation and of the adoption of artificial intelligence (AI) and machine learning (ML) solutions. This has enabled us, to accelerate R&D, improve manufacturing and commercial performance, and bring novel drugs and vaccines to patients faster, all in order to improve health and save lives. The Digital Team at Sanofi is a unique data-driven team. We pride ourselves on being data obsessed and highly focused on using state of the art processes along with global technologies to drive impact to our solutions. We measure our insights and products based on how they perform across the globe and hold ourselves to the highest regard as our solutions can impact millions of lives. When tackling a problem, we do not just ask how we will create a solution, but how we will create a solution that reaches across the world with the best possible societal outcome. If you are passionate about improving the health and wellness of people across the globe using Data as your means, then you should look no farther than the Digital Team here at Sanofi. Join us on our journey in enabling Sanofi’s Digital Transformation through becoming an AI first organization. AI Factory - Versatile Teams Operating in Cross Functional Pods: Utilizing digital and data resources to develop AI products, bringing data management, AI and product development skills to products, programs and projects to create an agile, fulfilling and meaningful work environment. Leading Edge Tech Stack: Experience build products that will be deployed globally on a leading-edge tech stack. World Class Mentorship and Training: Working with renowned, published leaders and academics in machine learning to further develop your skillsets. Who You Are: The Data Management Analyst of Data Quality is responsible for the technical implementation and management of data profiling, data quality and data governance solutions in a cloud environment. This role involves configuring and maintaining these tools to ensure that data is well-governed, cataloged, and accessible in a secure and compliant manner. You take pride knowing your work enables innovation and helping Sanofi build better solutions. Key Responsibilities: Designs, develops, and documents the standard data quality rules that can be applicable for all data assets. Ability to code Informatica Data Quality or Informatica Cloud Data Quality (CDQ) mapplets, workflows, and rules for deploying data quality rules and bring up scorecards in CDGC. Provide expertise in all aspects of data quality, including profiling, validation, standardization, and error handling using Informatica IDQ or CDQ/CDI and CDGC. Stays informed of leading practices, emerging tools and technologies and enterprise initiatives to provide ongoing improvements and recommendations for data quality rules maintenance, along with data profiling and data catalog. Serves as a liaison between the business and technical stakeholders to develop quality rules and controls through profiling; participate in the identification and remediation of data quality issues in the functions. Collaborate with stakeholders to understand data quality use cases and recommend what enhancement are required to the existing Data Quality Framework. Provide technical guidance on Data Quality best practices, technical capabilities, and troubleshooting issues. Ensure data security and compliance with relevant data protection regulations (e.g., GDPR, HIPAA) by implementing access controls, encryption, and auditing mechanisms. Collaborate with Program Management team to update project/program plan, report risks/issues, discuss mitigation strategy, program status. Partner with Data Stewards across the organization to operationalize all aspects of Data Quality, to support effective data decisions, escalations, and issue resolution. Create and maintain documentation on data processes, data models, and data flows for the organization. Provide training and support to end-users and data stewards to promote data governance best practices and awareness. Key Requirements: Bachelor’s degree in computer science, Information Technology, or a related field. Proven experience in data management, with a focus on Informatica CDGC or Informatica AXON, EDC, IDQ,CDQ, CDP, CDI. Proficient at writing SQL queries and verifying the results. Strong understanding of data governance principles, data quality, data integration, and data security. Familiarity with data protection regulations and best practices. Proficiency in data modeling, data quality, metadata management, and data cataloging. Excellent communication and teamwork skills to collaborate with cross-functional teams. Certification in Informatica CDGC or Informatica AXON/EDC/IDQ/CDQ data governance tools is a plus. Key Competencies: Servant Leadership. Communication and Facilitation with Good technical documentation skill. Understanding of Data Management principles, data governance best practices. Proficiency in Tool like Informatica Cloud Data Profiling (CDP), Cloud Data Quality (CDQ), Cloud Data Integration (CDI). Problem Solving capacity. Proficient at writing SQL queries and verifying the results. Adaptability and Continuous Learning. Good understanding of data governance principals. Familiar with RDBMS like Oracle, understanding the data modeling, and excel in PL-SQL. Good understanding of data governance principals. Nice to have: Experience working in life sciences/pharmaceutical industry is a plus. Certification in Informatica CDGC/IDQ/CDQ/CDP or similar data management tools is a plus. 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. Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com! 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. Follow Sanofi on Twitter: @SanofiCanada and on LinkedIn: https://www.linkedin.com/company/sanofi #DBBCA #DDB 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.
    • Full Time
    • 0
    • 0
    Reference No. R2719947 Position Title: Head CMC Data Science - VCDS - All gender (Unfilled) Department: Global Innovation & Digital Acceleration 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: Data Science Network Lead facilitates decision-based use case identification with platform leads, functional data scientists / data analysts, and bench scientists, with an aim of executing business strategies and / or supporting business decision-making with speed and quality, powered by connected data and driving enhancing value to the data generated within VCDS. S/He is the thought leader of available data modeling solutions within / outside of Sanofi network, and focuses on identifying, promoting, and applying potential model solutions, which deliver highest business valued. To do so, s/he needs to possess fundamental understanding & concepts of data engineering. S/He is the leading voice and figure, representing VCDS in various data science network & program settings, including but not limited to iCMC Digital Transformation, co-leading data & digital upskilling program within VCDS. Key Responsibilities: Leads and drives delivery of data strategies, including but not limited to identification, promotion, and adoption of use-case driven E2E data flow practices. Represents VCDS Data team in data science network and digital project teams as the subject matter expert, bringing broad knowledge and expertise in data science, machine learning, simulation and prescriptive modeling applicable to CMC space. Working with VCDS Business Data Architect and Functions builds prioritized list of use cases to drive data driven centricity of VCDS business process. Interfaces and aligns across the CMC space and involved R&D Functions to synergistically drive Advanced Analytic development and deployment. Designs, develops, and validates robust solutions and pipelines leveraging bioinformatics, statistical models, multivariate analysis, mechanistic and hybrid modelling, etc. for CMC data, covering both GMP and non-GMP activity needs. Performs exploratory data analysis, hypothesis generation and validation through data integration, advanced analytics, and visualization of VCDS vaccine design, both process parameters and discreet experiment data sets. Collaborates with scientific partners to advise on study design, readout selection and data formats, data analysis and modelling to generate actionable, reproducible, and interpretable insights. Proactively identifies, assesses, and internalizes emerging technologies and methods from internal and external data science network. Co-leads upskilling program for target population within VCDS on selected topics concerning advanced analytics, including but not limited to maintenance of a well-documented, reusable codebase, and traceable model history. Coaches develops and leads network of data scientists and analytical / process scientists on data analytics to deliver overall strategy. Co-examines existing data pipeline with business leaders and data architects, and identifies continuous improvement needs & priorities relevant to data engineering. Contributes to data continuum system design. Prepare and publish scientific papers and congress reports. HSE Requirement/Statement: Works within the policies, procedures and regulations as required by the Company and under the Occupational Health and Safety Act. Context of the job/Major challenges: Navigates ambiguous context and accountability to formulate a holistic and strategic picture. Strikes a healthy balance between delivery agility and decision-making hierarchy. Manages execution team and key stakeholders through impactful power of influence. Communicates clearly in a global context and across various functional areas as well as digital space. Drives problem-solving process with players from different technical background of different data and/or digital literacy levels. Travel might be required (NA, and Global); Frequency is subject to needs. Dimensions/Scope: VCDS population – approx. 400 +/- Global function coverage – 3, including AnSci, Global BioProcess Development, and Global Clinical Supply. Project teams to interact – # varies, subject to system introduction cycles. Key interfaces external to VCDS – VRD Data Office, mRNA Data Office, Sanofi CMC Data Strategy, iCMC DT Program Leads, Digital Data Office. Key Requirements: PhD in data sciences, chemometrics, computer sciences or related discipline with a minimum of 8 years of relevant industrial experience or Master’s degree and a minimum of 11 years of relevant industrial experience. Trained and operational in Agile methodology. Proven learning agility to pivot quickly from learner to influencer & coach’s role. Track records of team-based problem-solving practices. Demonstrated experiences in developing complex data analytics workflow – machine learning, multivariate analysis - on biologics processes. Advanced programming (Python and R), data analytics and modeling skills with experience developing data visualization solutions, process & workflow automation and deploying solutions to the cloud. Advanced knowledge of ETL tools such as Dataiku to build data flows, pipelines and outputs products such as dashboards, output files and visualizations. Intermediate to advanced knowledge of data architecture, data warehousing, functional and acceptance testing. Proven skills in leading complex data OR digital projects in an international / matrixed environment with both internal and external resources. Understanding of vaccine development processes. Fluent in English (speaking and writing). Structured, goal-oriented and highly motivated to deliver results under high pressure. Team player with excellent communication and presentation skills. Coaching and mentoring skills, supporting development of scientists in the area of data science. 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. Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com! 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. Follow Sanofi on Twitter: @SanofiCanada and on LinkedIn: https://www.linkedin.com/company/sanofi #GD-SP #LI-SP 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.
  2. Sanofi

    Technologist - Toronto, ON

    • Full Time
    • 0
    • 0
    Reference No. R2722565 Position Title: Technologist Duration: Fixed-Term Contract end date: December 20, 2024. Department: Viral Media 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 Major Activities of the Job: ​Perform daily media production activities including new formulations requested by R & D and Development and provide administrative and technical support in media production related activities: Perform daily media production activities including new formulation requested and provide administrative and technical support in media production related activities. Perform lab work, including aseptic manipulations, sterile filtration, and provide technical assistance in preparing new products. Check inventory of raw materials including requirements and expiry dates. Provide data/information for recording of raw materials and supplies. Check daily schedule, BPRs -- Print labels required for the day. Check inventory of media and ready for daily shipping. Perform Cycle Count of raw materials and Media. Maintain Inventory accuracy. Maintain BOMs and Routings. Writing new and revising existing SOPs: Review SOPs to ensure their compliance with cGMP: -Review is performed yearly to approx. 300 SOPs -New SOPs written as required Liaison with QA/QC for new or revised changes to regulations Data trending test results for specification compliance to be identified in SOPs. Formulation of liquid media which the procedures are delicate, and the accuracy is critical: Perform compounding, reconstitution and formulating of existing production requirements. Prepare new products and establish procedures requested by R & D and Development by first performing small scale manipulations to formulations to achieve desirable results, then perform step-by-step sealing up to the desired production batch size. Report and provide data collected from the scaling up process to the Media Department and to R &D Make suggestion to what equipment is necessary to maximize the efficiency of the scaling up. Perform in-house testing of pH, Osmolality, Limulus and Specific Gravity testing. Perform trending of test results by collecting test data to determine desirable limits of a particular test. Perform calibration and maintenance of testing and weighing devices. Perform aseptic manipulations in the preparation of sterile media. Provide technical assistance, trouble shooting and perform BRP transactions: Provide technical support and resources to improve productivity and efficiency. Provide technical assistance within the department and to external queries. Data entries and BRP transactions. Retrieve BRP data so as to provide necessary information for ordering raw materials and supplies. Provide technical information so as to purchase proper new equipment: i.e., Sucrose Pump, mixer. Distribution and delivery of media to users throughout Connaught: Retrieve orders from BRP as well as hard copy Material requisitions. Check availability and status of media. Communicate media inventory status to users, prepare Advance Release forms and arrange shipment of products to proper destinations. Communicate media product conditions to users and transport to ensure conditions of product are maintained: i.e., Serum must be received in frozen condition. Temperature must be maintained during shipment. Perform critical procedures to ensure satisfactory results and to carry out daily production routine smoothly: Daily flushing of W.F.I. system. Ensure availability of bulk diluent tanks for production of Diluents. Ensure availability of thawed serum to be used on the required date. Perform non-routine work such as preparing TRs for serum testing, arrange retesting of raw materials with MDC & Q.C. Perform daily environmental monitoring of various areas within the department during production. Minimum Qualifications: Minimum three (3) years College Diploma (Chemistry, Chemical Technology, Biology/Microbiology), plus a minimum of two (2) years of previous relevant work experience. Preferred (4) years bachelor's degree BSC (Chemical Engineer/Technology), plus a minimum of 18 months previous relevant work experience. Knowledge of chemistry/microbiology and mathematics Knowledge of F.D.A, H.P.B, E.P and cGMP/cGLP Basic mechanical skill and knowledge Aseptic Techniques Computer knowledge (BRP, LINQ, SAP, data entry and trending analysis. Manual dexterity, Safety Oriented, Teamwork, Responsible and reliable with Good Verbal and written communication. Hours Of Work: Inclusive from Monday - Friday: 1:00p.m.- 9:00p.m This is subject to change at any time, and it should not be construed as limiting the right of the company to make such change to meet the requirements of the operation. 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. Watch our ALL-IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com! 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. Follow Sanofi on Twitter: @SanofiCanada and on LinkedIn: https://www.linkedin.com/company/sanofi #GD-SP #LI-SP 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.
    • Full Time
    • 0
    • 0
    Reference No. R2716173 Position Title: Clinical Trial Application Manager Department: Development ​ Location: Mississauga, Ontario About Sanofi Specialty Care Sanofi's specialty care business unit focuses on rare diseases, rare blood disorders, neurology, immunology, and oncology.  Sanofi's ambition is to leverage science and innovation to improve people’s lives and be the industry leader in immunology and oncology. Its approach is shaped by a long history of developing highly specialized treatments and forging close relationships with physician and patient communities. 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: This position is primarily responsible for the Regulatory Affairs project management and submission of initial Clinical Trial Applications (CTAs), amendments, responses, and updates. Key Responsibilities: Collaborate with internal cross-functional teams (eg. Regulatory, Regulatory CMC, Clinical, etc.) to ensure high-quality regulatory submission of initial CTAs, amendments, responses, and updates. Ensure pre-CTA meeting requests, initial CTA applications, and maintenance of CTAs through the duration of clinical studies are in alignment with internal defined strategies to meet agreed upon timelines and in compliance with Health Canada (HC) Regulations and issued due dates. Ensure clinical supply labels adhere to local regulations. Maintenance of internal databases updates in timely manner as required. Provide Regulatory CTA expertise in support of clinical study feasibility and start up activities as needed. Oversight and accountability for study-related submission activities for electronic Trial Master File (eTMF). Support corporate audits and HC inspections of study sites as necessary. Maintain awareness and knowledge of new and changing CTA requirements. Key Requirements: University degree in Health Sciences Minimum 2 years of experience in Regulatory Affairs. Self-motivated, action and result oriented Excellent negotiation, communication, and strong interpersonal skills Good organization and planning skills. Ability to multitask and manage ambiguity/versatility Critical decision-making Strong knowledge of drug development, clinical study management, Health Canada requirements, ICH, GCP, site management and monitoring Experience in the pharmaceutical industry in drug development including clinical research and Regulatory Affairs Languages: English (written and spoken) French is an asset Computer Knowledge: MS Outlook, Word, Excel, PowerPoint, Adobe Acrobat Veeva Vault database familiarity is an asset Travel: Occasionally 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. Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com! 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. Follow Sanofi on Twitter: @SanofiCanada and on LinkedIn: https://www.linkedin.com/company/sanofi #GD-SG #LI-GZ 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.
  3. Sanofi

    Technologist - Toronto, ON

    • Full Time
    • 0
    • 0
    Reference No. R2722568 Position Title: Technologist Duration: Fixed-Term Contract end date: December 20, 2024. Department: Viral Media 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 Major Activities of the Job: ​Perform daily media production activities including new formulations requested by R & D and Development and provide administrative and technical support in media production related activities: Perform daily media production activities including new formulation requested and provide administrative and technical support in media production related activities. Perform lab work, including aseptic manipulations, sterile filtration, and provide technical assistance in preparing new products. Check inventory of raw materials including requirements and expiry dates. Provide data/information for recording of raw materials and supplies. Check daily schedule, BPRs -- Print labels required for the day. Check inventory of media and ready for daily shipping. Perform Cycle Count of raw materials and Media. Maintain Inventory accuracy. Maintain BOMs and Routings. Writing new and revising existing SOPs: Review SOPs to ensure their compliance with cGMP: -Review is performed yearly to approx. 300 SOPs -New SOPs written as required Liaison with QA/QC for new or revised changes to regulations Data trending test results for specification compliance to be identified in SOPs. Formulation of liquid media which the procedures are delicate, and the accuracy is critical: Perform compounding, reconstitution and formulating of existing production requirements. Prepare new products and establish procedures requested by R & D and Development by first performing small scale manipulations to formulations to achieve desirable results, then perform step-by-step sealing up to the desired production batch size. Report and provide data collected from the scaling up process to the Media Department and to R &D Make suggestion to what equipment is necessary to maximize the efficiency of the scaling up. Perform in-house testing of pH, Osmolality, Limulus and Specific Gravity testing. Perform trending of test results by collecting test data to determine desirable limits of a particular test. Perform calibration and maintenance of testing and weighing devices. Perform aseptic manipulations in the preparation of sterile media. Provide technical assistance, trouble shooting and perform BRP transactions: Provide technical support and resources to improve productivity and efficiency. Provide technical assistance within the department and to external queries. Data entries and BRP transactions. Retrieve BRP data so as to provide necessary information for ordering raw materials and supplies. Provide technical information so as to purchase proper new equipment: i.e., Sucrose Pump, mixer. Distribution and delivery of media to users throughout Connaught: Retrieve orders from BRP as well as hard copy Material requisitions. Check availability and status of media. Communicate media inventory status to users, prepare Advance Release forms and arrange shipment of products to proper destinations. Communicate media product conditions to users and transport to ensure conditions of product are maintained: i.e., Serum must be received in frozen condition. Temperature must be maintained during shipment. Perform critical procedures to ensure satisfactory results and to carry out daily production routine smoothly: Daily flushing of W.F.I. system. Ensure availability of bulk diluent tanks for production of Diluents. Ensure availability of thawed serum to be used on the required date. Perform non-routine work such as preparing TRs for serum testing, arrange retesting of raw materials with MDC & Q.C. Perform daily environmental monitoring of various areas within the department during production. Minimum Qualifications: Minimum three (3) years College Diploma (Chemistry, Chemical Technology, Biology/Microbiology), plus a minimum of two (2) years of previous relevant work experience. Preferred (4) years bachelor's degree BSC (Chemical Engineer/Technology), plus a minimum of 18 months previous relevant work experience. Knowledge of chemistry/microbiology and mathematics Knowledge of F.D.A, H.P.B, E.P and cGMP/cGLP Basic mechanical skill and knowledge Aseptic Techniques Computer knowledge (BRP, LINQ, SAP, data entry and trending analysis. Manual dexterity, Safety Oriented, Teamwork, Responsible and reliable with Good Verbal and written communication. Hours Of Work: Inclusive from Monday - Friday: 1:00p.m.- 9:00p.m This is subject to change at any time, and it should not be construed as limiting the right of the company to make such change to meet the requirements of the operation. 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. Watch our ALL-IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com! 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. Follow Sanofi on Twitter: @SanofiCanada and on LinkedIn: https://www.linkedin.com/company/sanofi #GD-SP #LI-SP 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.
  4. Sanofi

    Technologist - Toronto, ON

    • Full Time
    • 0
    • 0
    Reference No. R2722570 Position Title: Technologist Duration: Fixed-Term Contract end date: December 20, 2024. Department: Viral Media 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 Major Activities of the Job: ​Perform daily media production activities including new formulations requested by R & D and Development and provide administrative and technical support in media production related activities: Perform daily media production activities including new formulation requested and provide administrative and technical support in media production related activities. Perform lab work, including aseptic manipulations, sterile filtration, and provide technical assistance in preparing new products. Check inventory of raw materials including requirements and expiry dates. Provide data/information for recording of raw materials and supplies. Check daily schedule, BPRs -- Print labels required for the day. Check inventory of media and ready for daily shipping. Perform Cycle Count of raw materials and Media. Maintain Inventory accuracy. Maintain BOMs and Routings. Writing new and revising existing SOPs: Review SOPs to ensure their compliance with cGMP: -Review is performed yearly to approx. 300 SOPs -New SOPs written as required Liaison with QA/QC for new or revised changes to regulations Data trending test results for specification compliance to be identified in SOPs. Formulation of liquid media which the procedures are delicate, and the accuracy is critical: Perform compounding, reconstitution and formulating of existing production requirements. Prepare new products and establish procedures requested by R & D and Development by first performing small scale manipulations to formulations to achieve desirable results, then perform step-by-step sealing up to the desired production batch size. Report and provide data collected from the scaling up process to the Media Department and to R &D Make suggestion to what equipment is necessary to maximize the efficiency of the scaling up. Perform in-house testing of pH, Osmolality, Limulus and Specific Gravity testing. Perform trending of test results by collecting test data to determine desirable limits of a particular test. Perform calibration and maintenance of testing and weighing devices. Perform aseptic manipulations in the preparation of sterile media. Provide technical assistance, trouble shooting and perform BRP transactions: Provide technical support and resources to improve productivity and efficiency. Provide technical assistance within the department and to external queries. Data entries and BRP transactions. Retrieve BRP data so as to provide necessary information for ordering raw materials and supplies. Provide technical information so as to purchase proper new equipment: i.e., Sucrose Pump, mixer. Distribution and delivery of media to users throughout Connaught: Retrieve orders from BRP as well as hard copy Material requisitions. Check availability and status of media. Communicate media inventory status to users, prepare Advance Release forms and arrange shipment of products to proper destinations. Communicate media product conditions to users and transport to ensure conditions of product are maintained: i.e., Serum must be received in frozen condition. Temperature must be maintained during shipment. Perform critical procedures to ensure satisfactory results and to carry out daily production routine smoothly: Daily flushing of W.F.I. system. Ensure availability of bulk diluent tanks for production of Diluents. Ensure availability of thawed serum to be used on the required date. Perform non-routine work such as preparing TRs for serum testing, arrange retesting of raw materials with MDC & Q.C. Perform daily environmental monitoring of various areas within the department during production. Minimum Qualifications: Minimum three (3) years College Diploma (Chemistry, Chemical Technology, Biology/Microbiology), plus a minimum of two (2) years of previous relevant work experience. Preferred (4) years bachelor's degree BSC (Chemical Engineer/Technology), plus a minimum of 18 months previous relevant work experience. Knowledge of chemistry/microbiology and mathematics Knowledge of F.D.A, H.P.B, E.P and cGMP/cGLP Basic mechanical skill and knowledge Aseptic Techniques Computer knowledge (BRP, LINQ, SAP, data entry and trending analysis. Manual dexterity, Safety Oriented, Teamwork, Responsible and reliable with Good Verbal and written communication. Hours Of Work: Inclusive from Monday - Friday: 1:00p.m.- 9:00p.m This is subject to change at any time, and it should not be construed as limiting the right of the company to make such change to meet the requirements of the operation. 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. Watch our ALL-IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com! 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. Follow Sanofi on Twitter: @SanofiCanada and on LinkedIn: https://www.linkedin.com/company/sanofi #GD-SP #LI-SP 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.
    • Full Time
    • 0
    • 0
    Reference No. R2721360 Position Title: Inventory Handler Duration: Fixed-Term - Contract, End Date: December 20, 2024 Department: Production Logistics Management 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. Major Activities of the Job Delivering product to packaging lines in a timely fashion, also reconcile in-process and finished products, complete appropriate documentation and physically transfer product: Product is supplied to the machines according to the daily demands of the production floor. The product is removed from the fridge or deep freeze and placed at the appropriate machines for processing. Empty skids are placed at the appropriate machines for processing. Empty skids are placed at each machine so that when the labelling or packaging process is completed the filled skids can be placed back in the respective fridge or deep freeze. Lot numbers are then recorded on a fridge map to identify the product location. Changes are made daily as product is placed into refrigeration and a product is released for shipping. In process product from France, US or internal are reconciled prior to delivery to F&P for further processing. On completion of a process complete appropriate documentation and physically transfer product to correct storage locations. Organizing the storage of product under controlled temperature conditions: Product must be organized under storage conditions so that it can be easily found and retrieved. Organization must be controlled and logical to meet GMP requirements. The organization must facilitate movement of product between various storage sites and buildings. Transferring product between storage sites and product disposal process: Transfer between buildings and storage sites must be carried out to maintain the production schedules, and done safely to protect the product. Temperatures must be strictly controlled, product on the skids must be properly wrapped and identified, and securely mounted within trucks or on fork lifts. A great deal of lifting is required for this activity and work is often carried out in cold rooms. BRP transfer documents showing product, lot#, location etc., must be filled out to ensure BRP accuracy for product transfers between buildings 50, 83, 90 and 91. Perform cycle counts on a weekly basis and follow up on cycle count discrepancies. Product Disposal. In-process material for discards (i.e. broken glass, product, etc. is transferred to 83 dock for disposal pick up). Product identified for disposal is reconciled against the MOO (Material Disposition Order) and packaged appropriately (i.e. bagging of live virus material) and arrange for transportation to Building 77. Disposal documentation is filed. Monitoring freezer and refrigerator performance: Must monitor daily temperature recording for 13 refrigerators and 2 freezers located in buildings 50, 90, and 83. Must account for recording irregularities, change document readings and conscientiously do it to meet cGMP. On an annual basis collect thermometers deliver to QC Meterology for certification, again to meet cGMP. General housekeeping duties. On call for sundry labour: General housekeeping duties include periodic sweeping of the fridge and deepfreeze. Stacking skids and re-organizing material on the packaging floor. Transfer to proper storage locations for material received by Filling & Packaging such as media to incubators, material for refrigerated storage, packaging materials to the press room and the packaging floor and primary components such as ampoules to filling are delivered. Product Releases: Responsible for retrieving released product from storage locations and delivery to shipping. Upon released product transfer to shipping repackage all part containers, reconcile entire lot against the Packaging Work Record and document the transaction on the FPW sheet and distribute this documentation to CPIC, shipping and occasionally receiving. Physically transfer released product to the Shipping Department. P&P Operator functions including WFI sampling packaging equipment operation: The following duties are performed as required throughout the Filling & Packaging Department as required. The duties are itemized as follows: F&P Department: Perform WFI sampling and deliver samples to QC. Operate Zebra labeler to print carton labels for PWR orders. Operate and imprint lot number and expiry dates to cartons using the Graseby Allen printer. Prepare "Dummy" packages for use by Marketing department Packaging Department: Perform operator and examiner duties on Noack, Jones, IWKA, Line 1&2 or Brevetti Ampoule Inspection line as required. Operate Gilowy and Metromatic vial washers. Minimum Qualifications Minimum Grade 12 (Basic Science, Math and Computer) plus a minimum of one (1) year of previous relevant work experience. Reach Truck Certificate Forklift Certificate D License for Trucks G.M.P. Techniques Mathematics Certified Forklift Operator Sterile Techniques S.O.P.'s Mechanical Aptitude Organizational Skills, Accuracy, Written Communication Hours Of Work Inclusive from Monday – Friday: 7:00 a.m. – 3:00 p.m. 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. Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com! 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. Follow Sanofi on Twitter: @SanofiCanada and on LinkedIn: https://www.linkedin.com/company/sanofi #GD-SP #LI-SP 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.
    • Full Time
    • 0
    • 0
    Responsibilities: Collaborating with the F&P team on short term process improvements, capital equipment qualification, and facility upgrades.Support the closure of deviation investigations.Support the closure of corrective and preventive actions (CAPAs) to reduce or eliminate reoccurrence of deviations through administration and execution of action items.Work alongside representatives from other departments (e.g. Engineering, Validation Quality Operations, etc.) and on input from F&P Managers to support the execution of action items.Assist technical writers with documentation changes (SOPs/BPRs) to meet GMP requirements.Assist with documentation filing. Basic qualifications: Must be currently enrolled as a student at an accredited university and have completed at least one year of study, with plans to return to school after the assignmentWorking towards a degree inMinimum GPA of 3.0 on a 4.0 scale or 8.0 on a 12.0 scaleProficient in use of MS Office 2010, including Excel, Outlook, PowerPoint, and WordMust be legally entitled to work for Sanofi in Canada Preferred qualifications: Able to work independently and in collaboration with othersStrong organizational skills, attention to detail, and analytical skillsStrong written, verbal, and interpersonal communication skillsDesire to work within a team environmentStrong project management skills including organization, time management, and follow-up 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.
    • Full Time
    • 0
    • 0
    The Team: The Sanofi Pediatric Sales Team is responsible for the promotion and sales of vaccines for children and adolescents. We are a team of sales professionals, passionate in our commitment to prevent deaths from preventable diseases and to our customers and their patients. We share a culture of company and employee commitment where we value the talent of our team members and the achievement of our business goals. Job Highlights: The Vaccines Sales Professional (VS) is responsible for achieving/exceeding annual territory sales quotas across a diverse customer base within both public and private sectors (e.g. Physician Offices & Medical Groups, Integrated Health Networks, State Departments of Health, Vaccine for Children’s program, Federally Qualified Health Centers). The VS will engage customers through virtual and face to face interactions, achieving the optimal reach, frequency, and outcomes through appropriate planning and call implementation. The VS is required to develop and maintain expertise in disease and product knowledge, utilization of business data, business planning and organization, customer engagement and selling skills, team collaboration, technical skills, and territory administration. The VS is expected to have a thorough understanding of the national brand strategy, brand messaging and resources to effectively implement specific account action plans based upon their unique marketplace. The VS is required to develop a strategic partnership with his/her customers using the Sanofi Pasteur sales model to uncover customer business needs and identify product/non-product opportunities to address their needs. VS is responsible for embracing team selling by communicating, collaborating, and orchestrating with other appropriate field and home office team members to ensure an aligned Sanofi Pasteur approach to customers. Basic Qualifications: Bachelor of Arts (BA) or Bachelor of Science (BS) degree from an accredited four-year college or university (or the equivalent if education obtained outside of the United States) 2 years of pharmaceutical, business to business sales and/or medical experience Other pharmaceutical experience where individuals have demonstrated the ability to influence others may be considered (marketing, operations etc.) Preferred Qualifications: Candidates who reside within the territory or a commutable distance The Fine Print: Candidate possesses a valid driver’s license and a record of safe driving according to Sanofi policy Candidate is able to provide 2 years of performance review documentation Candidates must complete all fleet safety training and must maintain an acceptable driving record regarding accidents and incidents. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SP #LI-SP 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.
    • Full Time
    • 0
    • 0
    Job Title: Genomic Medicine BioAnalytics, Senior Scientist (Biophysics) Overview From Research and Development to Sales and Marketing, Sanofi offers a wide range of possibilities. Discover our open positions and become a health journey partner. Position Overview/Department Description We are seeking a motivated Senior Scientist to join our BioAnalytics Characterization group in Genomic Medicine Unit within Sanofi. The Genomic Medicine Unit (GMU), a part of Sanofi’s CMC Development organization, is dedicated to the establishment of best-in-class platforms to support development of life-changing advanced cell and gene therapy products, including recombinant AAV vectors, lipid nanoparticles, and cell therapy products. The BioAnalytics Characterization group uses advanced analytical techniques for in-depth structural and functional characterization of gene therapy/cell therapy products in support of drug development, from pre-candidate selection through commercialization. This role is an opportunity to gain experience in the rapidly growing modality of genomic medicine. The future of medicine is happening now at Sanofi – apply today and future-proof your career by putting yourself at the forefront of the next wave of therapeutics! The position will have the following responsibilities: Develop strategies and technologies to characterize various biopharmaceutical candidates of viral vectors for gene therapy and cell therapy. Perform biophysical/separation characterization techniques such as DLS, SV-AUC, AF4/FFF, MALS, NTA, CE, cIEF, MFI Design and perform structure/function studies in collaboration with analytical development, process development and research groups. Author technical reports, study protocols and articles for publication; contribute to scientific literature and conferences. Write analytical sections of IND/IMPD filings. Mentor and provide technical oversight for early-career scientists. Basic Qualifications: Ph.D. degree in a Biochemistry, or Chemistry-related field with a minimum of 3 years’ relevant industry experience or MS with 7 years’ relevant industry experience or BS with a minimum of 10 years’ relevant industry experience Moderate familiarization and previous experience in several of the biophysical/separation techniques listed above Some experience leading the implementation new analytical technologies Experience characterizing proteins, viral vectors or cell therapies using multiple tools and orthogonal data to build and study protein and viral degradation and behavior. Excellent organizational, interpersonal, communication and problem-solving skills Candidates with no previous experience with gene and cell therapy modalities are still encouraged to apply! Success Profile Courageous Results-driven Proactive Problem-solver Leadership Team player Culture: Play to Win Growth Innovation Efficiency Collaboration Benefits: Health & Wellness Comprehensive coverage including medical, dental, vision, and health and wellness programs. Financial Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs. Culture At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer. Work/Life Balance Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options. “At Sanofi, we are guided by a deep appreciation and understanding of what it means to live with a rare blood disorder, and we learn by listening to the community – patients, caregivers, physicians, and other healthcare professionals.” Shannon Resetich US Head Rare Diseases & Blood Disorder Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ PDN 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.
    • Full Time
    • 0
    • 0
    Sanofi Genzyme, the specialty care business unit of Sanofi, focuses on rare diseases, multiple sclerosis, oncology, and immunology. We help people with debilitating and complex conditions that are often difficult to diagnose and treat. Our approach is shaped by our experience developing highly specialized treatments and forging close relationships with physician and patient communities. We are dedicated to discovering and advancing new therapies, providing hope to patients and their families around the world. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Job Title: Sr. Director, Market Development - Respiratory Primary Location: United States- Cambridge, Massachusetts Position Summary: This individual’s primary responsibility will be to develop integrated marketing and educational strategies and tactics to support best-in-class commercialization of Dupilumab and future pipeline assets within the respiratory market. A key responsibility will be to develop and support the short-term and long-term marketing and educational strategies, programs, and tactics associated with marketing Dupilumab in asthma, nasal polyps and COPD globally. Subsequently, this individual will be responsible for implementing market shaping initiatives for health care providers, key respiratory congresses, disease treatment advocacy organizations, and other key stakeholders. This position will interface with international thought leaders, international patient advocacy associations, Sanofi-Genzyme leadership, the Sanofi Genzyme Global Dupilumab Development & Launch Unit, Regeneron alliance partners, Field Medical Leadership, Regulatory, Public Affairs, Medical Affairs, Product Communications and lead medical education agency efforts. Role Responsibilities: Translate the science into actionable and impactful marketing and educational strategies and tactics that resonate with core physician targets Manage key thought leader influence and centers of excellence mapping strategy, research & execution Develop Market Development launch readiness plan with ownership of specific pre-launch deliverables and KPIs Develop the Peer-to-Peer education strategy and program along with potential outcomes measurement Coordinate efforts with Medical (Medical Leadership, RML Team, Publications, Outcomes etc.) for appropriate alignment Develop and maintain strong relationships with internal stakeholders and cross-functional teams that support the brands Manage agencies and vendors as needed to develop and execute industry leading marketing and educational programs Develop a comprehensive understanding of the disease state(s), the competitive landscape and the overall market to develop high-impact and differentiating market conditioning strategies/tactics Advisory Board Planning and Management along with management of physician working groups Coordination of Competitive Intelligence(CI) and development of competitive containment/positioning strategy and plan Experience Qualifications: Bachelor Degree and 8-10+ product/brand management, and/or strategic marketing, commercial / business development with product launch experience in pharmaceutical or biopharmaceutical industry. A comprehensive understanding of the dynamics driving the global health care environment. Ability to quickly understand and communicate all clinical data / publications to support business objectives. In-depth understanding of the respiratory market, and experience developing Key external experts Understanding of market research, creative development and experience with regulatory review/approval process. Ability to interact widely and effectively within the company and with co-promote partner (i.e., on an interdepartmental and interdisciplinary basis). Experience working in an alliance Preferred Qualifications Demonstrated ability to understand and anticipate customer needs (internal and/or external) Strong project management skills Proven ability to cooperate transversally Exceptional communication skills Experience managing an advertising agency and related budgets Demonstrated analytical skills Passionate, confident, articulate, and comfortable in team environment Professional Skills Excellent organizational, interpersonal, and communication skills. Experience in international marketing (non-U.S.) within a complex, global commercial pharmaceutical or biotechnology organization Ability to lead in an ambiguous environment across different functions and company cultures Strategic thinking and prioritizing capacity Analytic and synthetic capacity with the ability to understand, simplify and communicate effectively with others Demonstrated ability to work effectively with cross-functional groups which may include Marketing, Sales, Research & Development, Medical Affairs, Business Development, Market Research, Public Affairs, Life Cycle Management, and Finance Behavioral competencies Performance orientation and ability to work and deliver along agreed timelines High level of Interpersonal/communication skills with ability to: Communicate and present on different levels in the organization Address the Marketing and Medical community as a target group Team oriented Readiness to travel (up to 40% of time) Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ 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.
    • Full Time
    • 0
    • 0
    Job Title: Global Research Postdoctoral Fellow - AI for Patient Stratification and Precision Medicine Our Team: The Computational Biology Cluster and the Biomarker & Patient Stratification Cluster are part of the Precision Medicine & Computation Biology (PMCB) global research function at Sanofi. This multidisciplinary group has developed a wealth of biomedical and multi-omics data and is at the frontier of developing advanced AI methodologies that influence the next generation of precision medicine. We seek a motivated postdoctoral fellow to work within the two cluster teams on next generation of foundational models for biology. Job Description: As a postdoctoral fellow, you will play a critical role in advancing target discovery and patient stratification methods through the harnessing of deep learning models that integrate multi-modal data. Your responsibilities will include: Collaborating closely with interdisciplinary teams to develop and optimize foundational deep learning models for identifying patient subgroups. Utilizing large datasets including genetic, transcriptomic, single cell, proteomic, imaging and electronic medical record data to train foundational deep learning models on disease specific context. Contribute to enhancing the precision of patient stratification and disease endotyping. Contributing to the identification and prioritization of targeted treatments for heterogeneous diseases. Developing biomarkers that facilitate the classification of patients into identified endotypes. Participating and leading manuscript preparations and submission, and presentation of findings in international forums internally and externally. Minimum Required Skills: Solid experience in deep learning and artificial intelligence methodologies. Knowledge and experience with foundational/generative AI models for omics or medical record data. Proficient in machine learning and deep learning frameworks such as TensorFlow or PyTorch. Proficiency in programming languages such as Python or R. Solid understanding of computational biology, bioinformatics, or a related field. Demonstrated ability in data analysis and visualization. Strong communication skills and ability to work in a collaborative multidisciplinary research environment. Preferred Skills: Knowledge of patient stratification and precision medicine concepts. Experience working with multi-omics data is a plus. Multi-GPU cloud computing experience Education: Ph.D. in Computational Biology, Bioinformatics, Computer Science, or a closely related field. Project Description: Patient stratification is a crucial component of precision medicine, as it enables the identification of distinct patient subgroups with different underlying molecular disease profiles, clinical manifestations and response to therapy. Stratification allows for the development of targeted treatments that are more effective, breaking observed efficacy ceilings while reducing adverse events for patients. For heterogenous diseases like Inflammatory Bowel Disease or Parkinson's disease (which has limited disease-modifying treatments available) patient stratification is especially important to identify the right targets for the right patients and thus improve clinical efficacy rates. With the availability of large amounts of multi-omics and electronic health record (EHR) data deep learning models can leverage an unprecedented wealth of information to identify patient subgroups that were previously unrecognized. However, one limitation of current patient stratification methods is that they typically consider only one layer of data, leaving a lot of value unused. By using deep learning models that can integrate multiple layers of data, we can improve the accuracy and precision of patient stratification. One challenge is that deep multi-omics and EHR data are rarely available together in the same cohort. Another challenge is that developing complex multi-omics biomarker models can be costly and difficult to translate into a clinical setting. To address these challenges, we propose to investigate deep learning models that can derive patient endotypes from multi-omics and real-world data, in disease specific context. We will consider foundational deep learning models that can be used to infer omics layers when they are not available and identify targets associated with disease progression in specific endotypes. Finally, we will develop simple biomarkers that can be used in a clinical setting to classify patients into the identified endotypes and inform on treatment decisions. We will explore various foundational models, including autoencoders, recurrent autoencoders, and adversarial neural networks. Foundational autoencoder models have already been developed for single cell multi-omic data integration (Lotfollahi et al.) and several models have been proposed for EHR (Landi et al.), including recurrent autoencoders that can be used to simulate records (Merkelbach et al.). Stanford HAI provides a recent review of existing method in this last domain. We will adapt and combine these approaches to integrate genetic, single cell, bulk transcriptomic, proteomic and EHR data, as well as other data type as relevant. These models will be used for patient clustering and visualization, and developing simpler classification models for clinical biomarkers. Furthermore, we will use these models to infer missing omics and medical record layers and to identify therapeutic targets. We will use a variety of datasets, including EHR and genetics data from private cohort data, to train pan-disease foundational models and disease specialized models. One of the important aspects of the project is to correct and adapt models across different technologies, populations and healthcare systems. This will enable us to develop models that are robust and applicable across different healthcare settings, thereby facilitating the translation of our findings into clinical practice. References : Lotfollahi, Mohammad, Anastasia Litinetskaya, and Fabian J. Theis. "Multigrate: single-cell multi-omic data integration." BioRxiv (2022): 2022-03. Landi, Isotta, et al. "Deep representation learning of electronic health records to unlock patient stratification at scale." NPJ digital medicine 3.1 (2020): 96. Merkelbach, Kilian, et al. "Novel architecture for gated recurrent unit autoencoder trained on time series from electronic health records enables detection of ICU patient subgroups." Scientific Reports 13.1 (2023): 4053. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA 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.
    • Full Time
    • 0
    • 0
    Clinical Research Director, Dupilumab The Clinical Research Director (CRD) Dupimab, Immunology and Inflammation Therapeutic Area, is responsible for contributing to the creation and execution of the clinical development strategy for Dupilumab in different indications. The CRD is expected to contribute to the growth of Dupilumab by both being a driver of clinical and scientific knowledge and advancing operational capabilities by challenging “the status quo”. Principal Duties & Responsibilities: Based upon an in-depth scientific understanding and extensive clinical experience, the CRD is responsible for: Drafting the abbreviated protocol of studies that he/she will be responsible for, and lead the creation of the clinical development plans (CDP), the clinical sections of integrated development plans (IDP), as well as overseeing the execution of such plans by the respective operational units in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs). He/she will also represent the project in relevant teams and the protocol review committee and review and comment the Investigator’s brochure. Lead and write clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP Assisted by related Sanofi Genzyme functions (e.g. clinical operations, project management, and procurement), responsible for defining timelines, budgets and contingency/risk management plans to assure successful execution of the clinical trials. Defends the CDP in front of internal management committees, regulatory agencies, and alliance partners, where applicable. The CRD may provide input into strategies to increase understanding of the mechanism of action of the drug including but not limited to the identification of biomarkers. On an ad hoc basis the CRD will be requested to contribute expertise to specific tasks such as the evaluation of potential in-licensing candidates for I&I therapeutic area and serves as the clinical advisor to research teams. Scientific and Technical Expertise: This position requires a strong scientific and clinical foundation in dermatology or respiratory or allergy as well as in all aspects of drug development. Advanced leadership skills and the ability to effectively collaborate with external partners, regulators, and diverse internal stakeholders and collaborators are essential prerequisites. Has and maintains deep scientific, technical and clinical expertise in dermatology or respiratory or allergy and related areas Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products Maintains visibility within the Immunology & Inflammation Therapeutic Area in general and more specifically in dermatology or respiratory or allergy to maintain credibility with internal and external stakeholders Ensure that all development activities are proactively planned and targeted towards timely achievement Interacts with opinion leaders and consultants. Owns (in collaboration with Project Team), the “Abbreviated protocol” for individual studies, the clinical sections of BLA, CDP and the clinical sections of the IDP and is responsible Clinician for the implementation of clinical strategy Influences the definition of the product value proposition and market access strategy (in collaboration with respective functions) and the focus of the research strategy, by providing input on existing clinical needs and approaches to clinical development strategies for research projects Complex Problem Solving As CDPs, BLAs/CTDs are sophisticated documents that require the ability to integrate highly complex scientific, medical and operational information, strong scientific, medical and analytical skills are required. An innovative and open-minded approach to problem solving is critical to arrive at the optimal solution for complex development challenges. Regulatory Responsibilities: Represents his/her project at key regulatory agency meetings as the medical spokesperson for the studies and projects Responsible for BLA clinical sections Ensures clinical data meets all necessary regulatory standards Supports registrations, label submissions and modifications Participates in Advisory Committee preparation Scientific Data Dissemination: Ensures timely submission and dissemination of clinical data Participate and author manuscripts and abstracts Supports the planning of advisory board meetings Establishes and maintains appropriate collaborations with knowledge experts In addition to the above activities the CRD must ensure that his/her contributions to the Global Project Team are conducted in compliance with current regulations, laws and guidance from FDA, EMA, and CHMP, as well as with Sanofi’s policies and procedures. Basic Qualifications: Medical Doctor (MD) or equivalent required; PhD desirable. Should be board certified or eligible in dermatology, respiratory, allergy, or immunology. Must have completed education and training at a medical school More than 5 years of clinical or scientific, or more than >10 years industry, experience within I&I or dermatology or respiratory (pulmonology, rhinology, ENT) drug development Strong scientific and academic background with deep understanding of the disease Clinical research experience in dermatology, allergology, respiratory drug development preferred Good networking ability in cross-cultural environment Strong interpersonal, communication, presentation, and negotiation skills across all levels of the organization Performance oriented with ability to work along agreed timelines and a focus on strategy and execution Outstanding communicator. Excellent problem-solving, conflict-resolution and decision-making skills Fluent in English (verbal and written communication) Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA 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.
    • Full Time
    • 0
    • 0
    Purpose of Role To support rare disease portfolio to plan and generate robust evidence to maximize the value propositions from both a global and US perspectives working within the market access team. Major Activities / Key Responsibilities Health Economics strategy, evidence generation and reimbursement support Oversee and guide development of quality research projects, economic models, trial design recommendations and other activities in support of programs/products . The incumbent interfaces with Clinical, Medical Affairs and business partners including Marketing, External Affairs and Market Access. He/she is accountable for the overseeing direct report at director level on product launches and post launch evidence generation activities. The incumbent will also lead planning, design, implementation and completion of innovative evidence based research programs that are consistent with program/product strategies. The research programs developed will provide appropriate evidence and/or tools to be used for internal decision making and for external audiences at product launch and over product life cycle. Develops strategies and provides new ideas and concepts on how to move the program, product or therapeutic franchise forward Manage the HEVA evidence generation strategy Manage team budgets and execution of ongoing studies according to budget and timeline expectations Identify new HEVA evidence generation opportunities to maximize lifecycle management Assist countries in developing or adapting health economic models and other materials for reimbursement, payer objection handling and other purposes Develop and maintain effective relationships with key internal stakeholders including North American Medical Affairs, European Medical Affairs, Sanofi Emerging Market regional teams, and Established Products. Sets strategic evidence generation priorities and direction for assigned responsibilities and is able to incorporate this into appropriate planning documents Takes a leadership role in the development of relationships and continued advocacy with external advisors in appropriate therapeutic areas Develops collaborative research relationships that provide data of value to decision makers. Leverages interactions to identify strategies that will improve the impact of research and build advocates for data Interacts with senior level management providing high level strategies and long term vision of assigned work Implementation of evidence generation tactics consistent with HEVA strategic goals including designing, budgeting, contracting, tracking, reporting, and publication plans Provides input to clinical and medical teams regarding opportunities to execute HEVA strategies within their planned research activities by identifying the appropriate evidence to collect and report Serves as a resource to commercial organization in terms of pricing, positioning and reimbursement of products based on economic evaluations About You All incumbents are expected to demonstrate effective communication, organizational and interpersonal skills to be able to work effectively as part of a multidisciplinary team. The incumbent is expected to work independently, but in concert with the direction provided by their management, in accordance with defined functional policies and precedents, budgetary guidelines, company values, ethics and applicable law. MSc or PhD or equivalent in health economics, epidemiology, statistics, biostatistics or related discipline Prior relevant experience working, at least 8 years, as a pharmaco-economist, HEOR and/or Market Access in consultancy, CRO or pharmaceutical/biotech Strong time-management and organizational skills Attitude to work well as a member of team and to build and manage relationships in a multi-cultural environment Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ 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.
    • Full Time
    • 0
    • 0
    Job Description At Sanofi, a global health care and pharmaceutical company, modeling and simulation approaches support strategy and critical decision making throughout the various phases of drug development. The Translational Disease Modeling (TDM) group at Sanofi is seeking to hire a highly talented Quantitative Systems Pharmacology (QSP) modeling scientist to support its R&D portfolio. The TDM group is part of Data & Data Sciences department within the R&D organization of Sanofi. This position is for a modeling scientist to develop and apply mechanism-based approaches of disease modeling. These modeling efforts represent key biological processes of the pathophysiology and a drug’s mechanism of action to enhance the understanding of disease and therapeutic response. QSP-model based simulations allow prediction of drug efficacy in virtual patients to inform clinical translation, and competitive differentiation. The successful candidate will be working within a dynamic, multidisciplinary environment to provide support for strategy and decision making in drug research and development. The position can be based in Cambridge, MA or Bridgewater, NJ. Title will be commeasurable with experience. This position at Sanofi is an exciting opportunity to chase the miracles of science to improve patient’s lives. Position Objectives Design, build, and apply QSP modeling approaches to support decision making within rare therapeutic area. Key Responsibilities Interface with project team in aligning M&S needs and develop QSP strategy to address needs. Develop, and implement innovative mechanistic modeling strategies to support project team M&S needs. Communicate modeling predictions to key stakeholders to inform strategy and decision-making. Collaborate with internal and external partners (CROs, consultants and academic collaborators) to support internal QSP efforts in key disease areas. Identify and interpret preclinical and clinical data critical for model development and refinement. Maintain state-of-the art knowledge of relevant modeling approaches and techniques. Contribute to abstracts and manuscripts. Perform job duties independently with minimal supervision, and mentor others to develop similar capabilities. Qualifications Ph.D. in Biomedical Engineering, Applied mathematics, Systems Biology/Pharmacology or related fields, with 5+ years of mathematical modeling & simulation experience specific for biomedical/pharmaceutical applications (experience within the pharmaceutical industry preferred). Track record of productivity, with evidence of independence in leading scientific projects. Hands-on experience with programming languages like Matlab/R/Julia (Matlab preferred). Experience in differential equation- based models and parameter optimization approaches. Understanding of theory, principles and statistical aspects of mathematical modeling and simulation. Good understanding of cell biology and physiology. Understanding of the basic principles of pharmacokinetics and pharmacodynamics also desired. Strong written, verbal and interpersonal communication skills. Desire to work within a team environment. Strong project management skills including organization, time management and follow-up are key. Knowledge And Skills Desirable But Not Essential Understanding of rare diseases and gene therapy *Title will be commeasurable with experience. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA 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.
    • Full Time
    • 0
    • 0
    Job Summary Provide leadership and guidance as the lead statistician on one or more project team(s), accountable for all statistical aspects of clinical/medical project(s). Act as statistical consultant within company. Major Duties and Responsibilities Lead statistician for moderate project / one or several indications of a project in either clinical development or post-marketing stage. Involved as lead statistician at study level. With minimal direction from group head, direct statistical support and provide scientific leadership for responsible project. Accountable for statistical aspects of clinical development/medical affairs plans, studies and submissions activities (when applicable), including quality, relevance to external stakeholders (e.g. regulatory authorities, medical journals), and scientific validity Mentor people working on the project. Promote teamwork, quality, operational efficiency, and innovation. Ensure project team compliance with SOPs and departmental standards. Plan and track project activities, timelines, and resource use. Ensure productive collaborations with other functions in the aligned project team, with other statistics project leaders and in communicating with senior leadership. Represent statistics in cross function working groups. Contribute to operation process optimization and provide inputs to statistics standards. Represent Sanofi Pasteur in cross-company activities such as consortiums or professional associations Required Education/Experience: PhD/MS in statistics or related discipline with at least 6-8 years of pharmaceutical experience Demonstrated strong study management, interpersonal and communication skills Broad knowledge and good understanding of advanced statistical concepts and techniques Proven experience in clinical development or post-marketing activities such as submissions, interactions with regulatory agencies or other external stakeholders Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. The salary median compensation and range for this position is $180,687. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the link, www.benefits.sanofiusallwell.com #GD-SP #LI- SP PDN 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.
×
×
  • Create New...