Technologist
PharmaBiotechRegulatory AffairsQuality Assuranceheorgmpgdpsascroinformsap
Job description
Reference no : R2874700 Position title: Technologist Duration: Fixed Term Contract - 11 months Location: Toronto, ON The start date for this role is Jan 2027. About the Job Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. Sanofi Vaccines Sanofi's global vaccines business unit partners with the public health, medical and scientific communities to improve access to life-protecting vaccines and increase vaccination coverage, while striving to develop new and improved vaccines to enhance health and well-being. At Sanofi, we chase the miracles of science to improve people’s lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people. About Sanofi We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. Main Responsibilities: 1. Coordinates and performs routine standard testing Responsible for coordinating and performing assigned routine immunochemical and instrumental assays within a team environment in accordance with existing SOPs (e.g. ELISAs, cell-based assays, SDS-PAGE/Densitometry, identity by Western Blot/Dot Blot/LC-MS/FTIR; HPLC, IC, GC, UV-VIS,TOC, Osmometry). Responsible for daily maintenance of test related equipment and system suitability, as required. Ensures that deaning procedures, calibration and or validation of equipment meets testing requirements, alerts others if issues arise. (ELISA plate washers/ readers, LC-MS and Chromatography systems, Densitometer, UV-VIS, FTIR, Biosafety cabinets, pipettes, balances, pH and Conductivity meters and weight sets.) Responsible for coordinating and performing routine in-house wet chemistry tests on in-process materials or final products (e.g. Nitrogen determination by micro-Kjeldahl, Aluminum by complexometric titration, identity by TLC). Perform wet chemistry/identity testing on Raw Materials according to in-house SOPs and Pharmacopoeias Assist with troubleshooting of invalid/unexpected results. Perform qualification of critical reagents according to SOPs, as required. Responsible for test reagent maintenance, inventory and supply and to ensure reagent supplies are replenished in a timely manner to avoid testing delays. 2. Documentation Testing and Support Documents Responsible for the timely and accurate completion and verification of test related documents to ensure on time delivery of test results. (e.g. data in LIMS, worksheets, log books, test requisitions, verification of calculations for accuracy, verification of entries and transcription of data, review of electronic data including audit trails, as applicable). Manage samples outsourced to approved contract labs including documentation preparation (Test Request and Shipping Form), review of test results (Certificates) from contract labs and transcription of results into LIMS or internal QC release documents, as required. 3. Maintenance of Quality Systems including adherence to GXPs and safety guidelines Ensures compliance is maintained in all daily activities by following SOPs (divisional, department & test), protocols and procedures as they apply. Reviews SOPs on an annual basis, documents training. Ensures that own training and qualification as per the qualification plan is current, with no overdue training. Responsible for identifying and notifying Manager of any laboratory non- conformances (deviations). Initiates LIRs and contributes to laboratory investigations and deviation reports as required, provides required documentation support to expedite closures of deviations. Participates in root cause analysis to identify appropriate corrective actions for CAPA and events. 4. General Maintenance of Work Area, Test Related Equipment, Chemicals, Reagents and Lab Supplies Responsible for general maintenance of work area including cleaning of lab benches and all work surfaces, equipment maintenance and disposal of biohazardous waste and chemical waste. Responsible for performing and completing the assigned lab duties in a timely manner. Maintain general lab equipment (e.g. balances, fridges, freezers, water purification systems) and perform routine calibration checks, cleaning and preventative maintenance as required. Ensure the operation of equipment is satisfactory. 5. Test Transfer, Validation & Implementation; Continuous Improvement Participates in projects for existing products and new products (e.g . collaborative studies with regulatory agencies and organizations on method comparison, assay/specification harmonization, new assay development, stability studies). Attend team meetings providing technical expertise on respective assays as required. Responsible for writing protocols and reports for test transfer and method validation as required. Execute studies under approved protocols for test transfer and new method validations, existing method revalidation. 6. Training / Skills Upgrade / Literature Review Complete On-the-job training according to current Lesson plans, and document as required. Participate in regularly scheduled GMP updates and safety training Complete the relevant and required tests and trainings on site procedures, USP, EP, ACS, etc. as required. Assist in training of new staff or existing personnel as required. Attend & participates (discussion & presentation) in relevant training sessions continuously. About You Education: Minimum four (4) years Bachelor's degree in (Chemistry, Biochemistry, Immunology, Biomedical Sciences or Molecular Biology), plus a minimum of two (2) years of previous relevant work experience. OR Minimum four (4) years Bachelor's degree and two (2) years Master's degree in (Chemistry, Biochemistry, Immunology, Biomedical Sciences or Molecular Biology), plus a minimum of eighteen (18) months of previous relevant experience. Skills and Knowledge: 1. Functional, Technical or Scientific Standard Analytical Lab Techniques (accurate transfer of weighed material, accurate volumetric measurement). Sound Knowledge and Practical Expertise in Immunochemical Assays. Sound Knowledge and Practical Expertise in Chemical/Biochemical Assays. Theoretical & Research related knowledge in Chemistry/Biochemistry, Immunology, Cell Biology. Sound knowledge of GMP requirements, including GDP. Computer knowledge – hardware, software, interfaces (e.g. MS Office, LIMS, SAP, FMS / BMS). Technical Writing Skills. Hours Of Work: Inclusive from Monday to Friday 8:00 AM - 4:00 PM. This is subject to change at any time and i
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