Manufacturing and Supply
Wo Wunder
der Wissenschaft
für Patient*innen
Realität werden

We’rean R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. 

Main Responsibilities:

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

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.

• 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.

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 staffor 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.

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.

• Preferred 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 in a laboratory, pharmaceutical, or Biotech Company.

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.

• Aseptic Cell Culture Techniques.

• Theoretical & Research related knowledge in Chemistry/Biochemistry, Immunology, Cell Biology.

• Mathematics.

• Sound knowledge of GMP requirements, including GDP.

• Computer knowledge – hardware, software, interfaces (e.g. MS Office, LIMS, SAP, FMS / BMS).

• Technical Writing Skills.

2. Supervisory, Managerial and Personal

• Accuracy/Attention to Detail.

• Organization and Planning.

• Work Independently, as well as in a Team Setting.

• Judgment.

• Problem Solving.

• Verbal & Written Communication.

• Instruction Techniques.

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.  

Hours Of Work:

• Inclusive from Monday to Friday 8:00 AM – 4:00 PM

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​This is subject to change at anytimeand it should not be construed as limiting the right of the company to make such a change to meet the requirements of the operation.

Mandatory Application Requirement:Your Workday application form must be complete, and a copy of your resume MUST be attached in the Workday application form, at the time yousubmityour Workday application, otherwise your application will not be considered for this position

Pay rate - $48.02 per hour

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team. 

• Discover endless opportunities to grow your talent and drive your career, whetherit’sthrough a promotion or lateral move, at home or internationally. 

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. 

• Takegood careof yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare,preventionand wellness program

Applications received after the official close date will be reviewed on an individual basis.​

This position is for a new vacant role that is now open for applications.​

AI Usage

"Artificial Intelligence” refers to any systems that use automated processes, including algorithms and machine learning, toanalyzedata and make predictions, inferences, decisions, or recommendations without direct human involvement. These systems may process personal information toidentifypatterns, improve services, or support decision-making. The Company may use Artificial Intelligence for purposes including, but not limited to, resume screening and hiring, scheduling interviews or meetings, conducting surveys, matching skills with potential job openings, interview scoring, ensuring compliance with regulations applicable to our industry, and activities related to performance evaluation. Information collected and processed by the Company’s Artificial Intelligence systems may include the personal information detailed above and calendar availability. It excludes the information collected and processed for monitoring purposes. You should contact Human Resources if you have a question or concernregardingyour personal information. You can also contact Canada’s Privacy Officer via Sanofi’s data subject request portal,  Data Subject Rights Webform.TheData Subject Rights Webform can also be used to request access or correction of your personal information and file a complaint.

Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop andretainhighly talentedemployees from diverse backgrounds, allowing us tobenefitfrom a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants.  Accommodations for persons with disabilitiesrequiredduring the recruitment process are available upon request. 

Thank you in advance for your interest.

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