Technologist

Reference no : R2867889 Position title: Technologist Duration: Fixed Term Contract - 11.5 months Location: Toronto, ON About the Job Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.​ Sanofi Vaccines Sanofi's global vaccines business unit partners with the public health, medical and scientific communities to improve access to life-protecting vaccines and increase vaccination coverage, while striving to develop new and improved vaccines to enhance health and well-being. At Sanofi, we chase the miracles of science to improve people’s lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people. About Sanofi We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. Main Responsibilities: 1. 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. Responsible for ensuring testing SOPs are accurate and reflect current testing procedures. Review existing SOPs & initiate revisions or writing of SOPs, responsible for ensuring SOP accuracy and timely updates, cascades changes to all staff affected by initiating SOP reviews. Contribute to protocols, reports and test summaries as required. (e.g. Qualification of critical reagents reagents, test transfers, test method validations). Responsible for updating and maintaining trending data as required. (e.g. trending of test standards and controls). Responsible for accurately compiling data for tests and products, for statistical reports, investigations, regulatory questions and or submissions as required. Responsible for ensuring accuracy of critical reagent inventory as related to responsibility. Responsible for management of documents in accordance with department and corporate policies (binding worksheets, filing, compiling documents for archival). 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. Act as change control initiator or leader as needed. Responsible for creating and reconciling controlled worksheets/supplements in a timely manner. Provides weekly testing information for general metrics to Manager. Ensures adherence to GMP guidelines and attendance at regularly scheduled laboratory meetings. Ensures adherence to safety guidelines as outlined in corporate and site policies. Responsible for reviewing SDS for reagents used and ensuring compliance with requirements. Reviews data in the building monitoring systems for equipment performance (e.g., freezer/refrigerator temperature charts). Reports any major laboratory or equipment damages/abnormalities to Manager and/or notify Security / Physical Plant, as well as initiate and follow-up on maintenance work orders. 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. Ensure the appropriate cleaning /equipment logs or other related records are completed and maintained as per the established procedures. Monitor and maintain inventory of test related materials and supplies. Liaison with purchasing, receiving and vendors. Document receipt of reagents according to the defined procedures. Affix proper labels to all reagents. Maintain the inventory and monitor the expiry of all chemicals, reagents, reference standards, test solutions, volumetric solutions used for testing and raw material retention samples, as applicable. Create and submit purchase requisitions for the lab supplies as required. Report damages/abnormalities to Manager o