Technical Manager, QC Chemistry

at  Sanofi

OVERVIEW

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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.

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.

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.

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.
• experience on Chemistry/Biochemistry instrumentation required (e.g. UV-VIS spectrophotometer, chromatography).
• experience in Quality Assurance/ QC preferred.
• experience with both GMP Document review and Test results review preferred.
• experience with equipment qualification preferred.
• 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.

RESPONSIBILITIES

Reference No. R2722400
Position Title: Technical Manager, QC Chemistry
Duration: Fixed-Term - Contract End Date: December 20, 2024
Department: Chemistry and Raw Materials
Location: Toronto, Ontario

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.