Job Description

Reference No. R2698800

Position Title: Technologist

Department: Chemistry

Duration: Contract: 11 months

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\xe2\x80\x99s 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

• 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/D0t Blot/LC-MS/FTIR\xe2\x80\xa2, HPLC, IC, GC, UV-VIS,TOC, Osmometry).
• Responsible for daily maintenance of test related equipment and system suitability, as required. Ensures that cleaning 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.

Documentation \xe2\x80\x94 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 [abs 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).

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 nonconformances (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.

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 or designate. Create work orders and follow-up on notifications for equipment, cleaning and maintenance services.

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 expenise 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.
• Contribute to the design of method improvements for routine tests performed in the department.
• Compile data and perform preliminary statistical analysis (as required); troubleshoot unexpected results as required. Analyze all relevant results and conclusions.
• Co-ordinate testing schedules with coworkers to support transfer and validation activities.
• Update all relevant documents as required, implements changes (e.g. SOP changes).
• Participate in department and corporate continuous improvement projects and activities using 5S and Lean Sigma principles.
• Provide ideas, suggestions to the manager and team to improve the ways of working and existing process.

Training /SkilIs upgrade/Literature Reviews

• 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.
• Attend available seminars on topics related to laboratory activities, as recommended by Manager.
• Perform literature searches to stay abreast of equipment/software upgrades and new technology.

Minimum Qualifications:

• Minimum of four (4) years Bachelor\xe2\x80\x99s Degree (Chemistry, Biochemistry, Immunology, Biomedical Sciences or Molecular Biology), plus a minimum of two (2) years of previous relevant work experience.
• Preferred two (2) years Master\xe2\x80\x99s Degree (Chemistry,Biochemistry,Microbiology), plus a minimum of eighteen (18) months of previous relevant work experience.
• ELISA plate reader/washer and Reader, Spectrophotometers (UV-VIS, ET-IR)
• Chromatography Systems (LC-MS, Ion Chromatography, GC and HPLC)
• Total Organic Carbon Analyzer, Osmometer, Densitometer
• Biosafety Cabinet, Fume Hood, C02 incubator
• Other common lab equipment (Computer, FMS/BAS, Calculator, Pipetting devices, burettes, centrifuge, analytical balance, pH meter, conductivity meter, hot plate, microscope, refrigerator, freezer, purification column, etc.)
• Standard Analytical Lab Techniques (accurate transfer of weighed material, accurate volumetric measurement)
• Sound Knowledge and Practical Expertise in Immunochemical/Chemical/Biochemical Assays
• Theoretical & Research related knowledge in Chemistry/Biochemistry, Immunology, Cell Biology.
• Sound knowledge of GMP requirements, including GDP
• Well developed Computer Skills.
• Excellent Communication skills.
• Detail-oriented individual.
• Ability to work independently and within a team setting.

Hours Of Work:

• Inclusive from Monday - Friday: 8:00a.m. \xe2\x80\x93 4:00p.m.

Pursue Progress.

Discover Extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn\xe2\x80\x99t happen without people \xe2\x80\x93 people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let\xe2\x80\x99s 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:

#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.

Sanofi