Sanofi Looking for Technical Manager, QC Chemistry at Toronto, Ontario, Canada Full Time

Position Title: Technical Manager, QC Chemistry

Duration: Fixed-Term – Contract End Date: December 20, 2024

Department: Chemistry and Raw Materials

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 Technical Manager’s activities will mainly pertain test coordination and approval, equipment qualification and test transfer.

The Technical Manager will support the QC Chemistry in approval and timely release of test results, and the associated activities related to critical reagents, control of documents and test performance monitoring.

The Technical Manager will support and lead instrument troubleshooting and equipment/software upgrades and qualification.

The Technical Manager will have the responsibility to create and update protocols, reports and SOPs related to routine testing and projects in addition to supporting audits and continuous improvements.

Key Responsibilities:

Review/verification/approval of tests and organizing of the test related documentation, as required (65%)

• Accountable for ensuring on time delivery of completed test documentation.
• Ensure accuracy and compliance with cGMP.
• Ensure documentation is expedited in a timely manner to facilitate the release of product to
• On a weekly basis monitor and track requirements for test approvals to ensure on time release of test results (including assay/reagent validation/update approvals).
• Review and approval of critical reagent qualification and expiry extension reports.
• Responsible for ensuring monthly review of logbooks are completed.
• Responsible for accurately compiling data for tests, products, trending for statistical reports, to support regulatory questions and/or submissions as required.
• Perform LIMS queries as required (for trending or other purposes).
• Responsible for organizing and management of documents in accordance with department and corporate policies.
• Coordinate with the Test Managers (i.e. people managers) to ensure timely test execution by analysts.

Equipment/assay troubleshooting, certification, qualification, validation, maintenance, verification, system checks and other activities (10%)

• Performs/assists with equipment/assay commissioning and decommissioning, qualification and validation.
• Coordinating maintenance and re-certification/recalibration of equipment.
• Following up on instrument alarms and printing charts, as required.
• Activities as they pertain to equipment preventative maintenance/calibration.
• Equipment troubleshooting.
• LIMS test build/update.
• The Manager will make decisions on troubleshooting to resolve testing issues while ensuring regulatory and quality compliance is met, and escalate issues as required.
• Develop and implement new procedures and processes to maximize efficiencies within the department. Improve and optimize testing procedures through test modifications and replacement, while investigating cost reduction measures.
• Refine and optimize test procedures to ensure most cost effective and efficient means are being utilized while ensuring compliance.
• Plan, co-ordinate and execute activities related to identified process improvements.

Quality systems and documentation (10%)

• Reviews existing SOPs and initiate revisions/approvals of existing or new SOPs, protocols, reports and test summaries as required.
• Responsible for ensuring SOP accuracy and timely updates, cascades changes to all staff affected by initiating SOP reviews.
• Manages activities related to Change Control and CAPA, as required.
• Responsible for notifying Manager of any laboratory non conformances.
• Leads investigations and provides required support and documentation to expedite closure of deviations.

Support responses to internal and external audits as required (5%)

• Compile data to support regulatory submissions, audits, and root cause analysis as required.
• Accountable to ensure the timely filing, and completion of all GxP documents associated.

Other laboratory administrative duties and HSE (5%)

• Placing orders and invoice management with external or internal vendors.
• Placing and following up on Facilities work orders in iShift.
• Implement Processes and procedures to ensure proper use and maintenance of PPE and safety equipment.
• Ensure that safety audits are carried out on a monthly basis and that deficiencies are reported and dealt with in a timely fashion.
• Ensure SDS sheets are current.

Training/skills upgrade/literature review (5%)

• Complete on-the-job training according to current lesson plan. Attend and participate in required training sessions continually.
• Support and comply with all Sanofi Pasteur health, safety and environmental policies, contribute toward meeting departmental goals; and demonstrate progress in preventing or reducing injuries and/or illness.

HSE Requirement/Statement:

• Works within the policies, procedures and regulations as required by the Company and under the Occupational Health and Safety Act.

Dimensions/Scope:

• This is salaried staff position with no direct reports.
• The Technical Manager will be responsible for test approval for assigned tests, and to ensure timeliness of released results based on the supply requirements.
• This role requires oversight of the departmental quality systems and to manage and write documents related to qualification and validation projects.
• The Technical Manager is expected to provide guidance and training to technologists on equipment and software, as required.
• Responsible to lead and manage CAPAs and CCRs under scope of responsibility, to ensure regulatory, quality and HSE compliance.
• Expected to troubleshoot instrument/software issues in addition to being involved in equipment qualification activities and test transfer.
• The Technical Manager will report directly to the Deputy Director of QC Chemistry.

Key Requirements:

• B.Sc. in Chemistry, Biochemistry or a related field, such as Biomedical Sciences.
• 2 years of experience in Pharmaceutical/Biotechnology setting or related experience.
• Previous experience on Chemistry/Biochemistry instrumentation required (e.g. UV-VIS spectrophotometer, chromatography).
• Previous experience in Quality Assurance/ QC preferred.
• Previous experience with both GMP Document review and Test results review preferred.
• Previous experience with equipment qualification preferred.
• Previous experience with instrument troubleshooting.
• Sound knowledge and experience working in the field of Chemistry, Biological Sciences, Biochemistry or a related field.
• Excellent understanding of GMP requirements.
• Sound knowledge and experience with Chemical and Biochemical analytical methods (e.g. UV-Visible spectrophotometry, Chromatography, TOC, conductivity).
• Sound statistical knowledge.
• Strong written and oral communication skills.
• Strong analytical and balanced decision-making skills.
• Complete work in a timely, accurate manner with minimal supervision.
• Ability to work independently as well as part of a team. Organizational skills, flexibility and efficiency are essential.

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.

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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.