Technologist - Vaccines

Reference No. R2741420

Position Title : Technologist- Vaccines

Duration : Fixed-Term - Contract End Date : May 31, 2027

Department : B100 DT (Days)

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.

Major Activities of the Job :

SeedProductionandtestingrelateddutiesforTetanusandDiphtheria :

Primary andSecondary (P&S)seedexpansion,puritytesting,gramstain, evaluationandrecovery ofTetanusandDiphtheriacultures forlargescale fermentationapplications.

Prepare and load lyophilizer for different seed lines for master and working seed stock. Separation and heat sealing the lyophilized cultures.

Evaluation on generated seed stocks for commercial licensed applications.

Prepare raw-reagents intermediate reagents and intermediate products for seed preparation. Final test and initial primary release of final stage of seed culture for inoculation into fermenters.

P & S propagation of working seed lines for process improvement or development applications.

Post verification / qualification of manufactured seed lines conduct requires testing, obtain Raw Material specifications sheet and submit to QA / RA for culture release.

Complete appropriate documentation and appropriate release.

FermentationofTetanusandDiphtheriaseed culturesandfermentationbatches :

Cleaning fermentors and related equipment, rinsing and preparation of fermentation equipment for sterilization and fermentation of batches.

Release of equipment for further processing.

Create, amend and update SOPs to perform necessary steps to formulate products. Where needed set-up, monitor and manipulate control towers to maintain or modify specific fermentation parameters.

Maintenance of the SPC data based for detailed data compilations.

Aseptically sample fermentation batch, perform and release purity test, and evaluate culture to continue fermentation or processing.

A critical understanding of the fermentation process, by- products and integrity measures. Proper documentation on the associated controlled documents.

Ensure chemical calculations, chemical additions and elemental requirements are met for the different fermentations. Preparations of solutions, dilutions and in-process diluents for products.

Strong understanding of dilutions and chemical compositions in solutions.

Trouble shooting problems arising within processes. Strong understanding of

fermentors, fermentor design, equipment integrity and testing (including pre

testing).

Batch clean- p and tum-over.

Recovery, purification, detoxification of toxins post fermentation :

Prepare chemical and equipment resources for harvesting of fermented batches.

Set-up of crude filtration units, ultra-filtration unit, and equipment for recovery, purification, concentration and detoxification of fermented batches.

Monitor, maximize, manipulate and document parameters for the recovery processing.

Filter and sterilize product, concentrate and purify products, then perform detoxification of toxins.

Evaluate primary release criteria for process continuation. Perform primary and secondar recoveries of toxins. Evaluate for processing criteria.

Strong understanding of filters and filtration. Strong understanding of commercial I product recovery equipment and protein recovery techniques.

Sample,testandevaluaterequiredpurityandin-processtestsrequired.Sample,prepare andselectQCreleasetestingsamples, evaluateuponcompletion :

Perform all required purity testing of Diphtheria and Tetanus during seed propagation, master & working seed creation, fermentation, and harvesting.

Evaluate and document purity of product prior to continuation of batch.

Prepare and deliver QC release MLD / L+ testing and required TRs. Receive results and evaluate.

Perform Specifies toxicity and sterility post tetanus incubation.

Utility and Facility Monitoring for Diphtheria and Tetanus Areas :

Obtain and verify required material for EM and utilities testing.

Monitor and perform aseptic EM required per product / per week, bi-weekly and monthly schedules.

Install, prepare, and flush chilling unit / air sampling unit for proper sampling application.

Sterilize I / P.S. lines, monitor and aseptically sample.

Aseptically perform required WFI / steam / compressed air sampling as per schedule.

Assist in SIR and EIR reports, assist in product testing if any.

Fill out required documentation and ensure that samples are delivered on time to their intended departments.

Creations, revisions and updating SOPs & BPRs :

Review SOPs every three years and update. Create new SOP if needed.

Receive updated SOPs and update SOP binders.

Ensure departmental training of new or revised SOP., support, amend and analyze data bases.

Montior, support, amend and analyze data bases.

Maintain current data bases.

No employee has a proprietary right to an activity or group of activities. Activities may be changed or reassigned to meet the needs of the operations.

Minimum Qualifications :

Minimum three (3) years Community College Diploma (Microbiology, Biochemistry, Biotechnology), plus a minimum of two (2) years of previous relevant work experience.

Preferred three (3) years University degree (Microbiology / Biology, Biochemistry, Protein Research), plus a minimum of one (1) year of previous relevant work experience.

Microbiological Understanding- growth kinetics

Aseptic techniques

Mechanical and processing techniques

Chemistry

Statistical, Analytical / Deductive reasoning

Protein Purification

Mathematics

Microbiology

Coordinating, organization, verbal and written communication skills

Hours Of Work :

Inclusive from Monday to Friday : 2 : 00 p.m. - 10 : 00 p.m.

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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.

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