Technologist - Flu Downstream

Reference no:
R2864342

Position title:Technologist - Flu Downstream

Duration: Fixed Term Contract - 2 years

Location:Toronto, ON

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and  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.

Execute downstream processing, sterile filtration of influenza drug substance

• Set up, maintain a variety of automated and manually operated equipment and perform production activities in downstream processes: clarification by centrifugation and TFF, purification by zonal centrifugation, splitting by continuous flow centrifugation, inactivation, diafiltration and sterile filtration of drug substance.

• Perform troubleshooting and assessment of processes and technical problems.

• Clean-in-place (CIP), cleaning-out-of-place (COP) of downstream equipment and vessels

• Provide training to personnel

• Execute and verify IQ/OQ/PQ validation and cleaning verification protocols.

• Perform other duties as assigned by department management throughout all stages of drug substance manufacturing related to B200 operations (MWS, Upstream and Downstream processes).

• Ensure all equipment, instruments and systems are properly assembled, installed, tested and maintained.

• Participate in preventive maintenance of production equipment and instruments.

• Sample processed materials and perform in-process testing according to procedures.

• Deliver samples to other departments on site as required.

• Perform area‑specific testing, utility sampling and environmental monitoring for production.

• Perform routine cleaning and disinfection activities in classified environments.

• Maintain and organize cleanroom in good cGMP state and ensure area is always inspection ready.

• Submit equipment/material orders and maintain inventory of spare parts, purchased materials for downstream processing.

• Maintain safe and clean work environment by following site procedures and cGMP regulations.

• Participate in facility preparation and inspection readiness, safety and process audits.

• Document, review and maintain production and monitoring activities for Influenza drug substance manufacturing

• Draft, review and revise cGMP documents (SOPs/SWis, batch records, protocols, change controls, reports and other manufacturing supporting documents).

• Analyze, enter & verify data on paper based or electronic documents.

• Follow all SWI/SOPs and comply to site policies and procedures.

• Perform and participate in continuous improvement and development projects.

• Initiate Deviations, CCR, CAPA in Quality system as needed and assist until completion as per committed due dates

• Participate in deviation investigations and root cause analysis.

• Follow HSE SOPs, identify and minimize risks, promote safety culture.

• Comply with HSE guidelines on the disposal of waste.

No employee has a…