Technical Group Leader - Flu Downstream

Sanofi•Toronto, ON

1d•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. 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. 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's degree (Biochemistry, Microbiology, Bioengineering, Biotechnology, Chemistry, Chemical Engineering, Pharmaceutical Sciences, other Life Science Degrees) plus a minimum of 36 months of previous relevant work experience.
Minimum 4 years Bachelor's Degree (Biochemistry, Microbiology, Bioengineering, Biotechnology, Chemistry, Chemical Engineering, Pharmaceutical Sciences, other Life Science Degrees) plus a minimum of 36 months of previous relevant work experience.
Sound Knowledge of Microbiology and protein purification.
Basic mechanical skill and knowledge.
Aseptic Techniques, Chemistry, Mathematics, 'GMP and GLP.
Computer skills, SAP, JMP, Visio, PCS, MES, e- BPR, e-logbook

Responsibilities

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.
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 transactions are done in a timely, accurate manner.
Oversee and support activities in required environmental monitoring systems.
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 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.
Perform activities as needed based on access levels on equipment.
Train and ensure technical staff comply with HSE requirements.
Ensure operators are equipped and use proper PPE when performing tasks.
Actively participate in activities done by HSE department and support HSE initiatives.
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.
Ensure production and office areas are kept in a tidy, GMP manner, following 5S guideline or equivalent
Clean and disinfect areas as required in SOP.
Coordinate and schedule work of technical staff in facility, equipment, and process improvement projects with Manufacturing Technology (MTech) and facility management (Engineering & Technical Services)
Assist implementation of facility, equipment, and process improvement projects
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
Collaborate with other departments for root cause analysis and assist with implementation of corrective actions.