Technical Group Leader-MWS

Sanofi•Toronto, ON

4d•$55•Onsite

About The Position

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. Join Sanofi's pioneering B200 operations in Downstream team as a Technical Group Leader, spearheading innovation in pharmaceutical manufacturing. Collaborate with industry experts to drive excellence in operations and lead transformative projects. This exciting opportunity offers a platform to make a tangible impact in the intersection of technology and healthcare. We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. 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.

Requirements

Minimum 3 years College Diploma in Biochemistry, Microbiology, Bioengineering, Biotechnology, Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related Life Sciences field.
Minimum of three (3) years of relevant work experience, or equivalent.
Proficiency in pharmaceutical manufacturing, protein purification, centrifugation, tangential flow filtration, and cGMP preferred.
Experience with both Automated and manually operated process equipment.
Strong understanding of Computerized systems, Data management systems, Quality management systems, SAP, SOPs, automation, and other relevant software/applications.

Nice To Haves

Bachelor’s degree (Biochemistry, Microbiology, Bioengineering, Biotechnology, Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related Life Sciences) preferred, with a minimum of three (3) years of relevant work experience.

Responsibilities

Administration of Influenza manufacturing activities.
Schedule and coordinate daily/weekly work of a group of technical staff in B200 as per area requirements.
Check and review Records, SOP, logbooks/e-logbooks, BPRs/e-BPRs, and monitoring charts for completion and accuracy of all documents as per GMP guidelines.
Ensure equipment is kept in good GMP condition (with preventive maintenance, validation and calibration)
Order and ensure adequate chemicals, supplies, and spare parts for equipment
Train and ensure technical staff comply to GMP and SOP requirements
Facilitate daily meetings and report findings to management
Initiate and file deviations and lead investigations
Coordinate and support units within department (Upstream, Downstream, MWS) and other outside departments (Maintenance, Automation, QO test labs, etc.) and ensure timely completion of production activities.
Perform other duties as assigned by Department Management throughout all stages of drug substance manufacturing
Supervise material handling in B200 Shipping, Receiving, and storage areas.
Administration of Data for Influenza manufacturing.
Coordinate, oversee, and confirm technical staffs completion of SAP activities/transactions
Capacity planning and scheduling of materials and personnel
Create work orders for ETS/Maintenance
Maintain master recipes and production inventory
Create and maintain process orders with authorization to change orders upon demand
Ensure all data input is completed accurately and in a timely manner such as investigation data, LIMs, deviation filing, change request forms, etc.
Perform activities in PCS and review data as required
Perform area specific activities, monitoring, maintenance.
Perform and delegate production calculations, measurements and release checks.
Ensure each cleaning meets standards set in SOP, records, and in accordance with GMP.
Observe in detail and report any process deficiencies, perform visual inspection of equipment for impurity and damage before and after cleaning.
Perform and delegate utility sampling and environmental monitoring as required and ensure completion on schedule
Train technical staff on problem solving and troubleshooting as required.
Ensure area is inspection ready. Knowledgeable to guide inspectors
Oversight of Health, Safety, and maintenance of GMP environment.
Train and ensure technical staff comply with HSE requirements
Ensure operators are equipped and use proper PPE when performing tasks.
Ensure operations are performed in an ergonomic way and escalate any potential hazards.
Help develop proposed solutions.
Ensure routine HSE checks and inspections are completed in a timely manner.
Ensure cleaning chemicals and equipment are stored and used as per HSE requirements and have SDS available.
Process improvement, development and preparation of trending reports.
Coordinate and schedule work of technical staff in facility, equipment, and process improvement projects with Manufacturing Technology (MTech) and facility management (Engineering & Technical Services)
Write or modify specifications, protocols and reports related to facility, equipment, including SOP's, BPR's.
Perform activities involved in IQ, OQ, and PQ for new equipment
Initiate CCR, CAPA in Quality system as needed and manage them until completion as per committed due dates