BRD Upstream Technologist
Toronto, Canada Sales
Job description
Job Description for Technologist BRD Upstream Platform
Job Title:
This position is for a Technologist in BRD Upstream Platform
Summary of Purpose/Major responsibilities:
Execute experiments and protocols to optimize bacterial/ animal cell growth and recombinant protein /virus production in bioreactors as part of vaccine process development. Document work done in lab books, work instruction templates, reports, etc.
Assist in the design of experiments and be responsible for performing development experimental studies to the agreed upon plan. Experiments require knowledge of cell growth, cell metabolism, product formation (eg: recombinant protein, virus), aseptic technique, batch and fed-batch cultures, and calculations. The control of bioreactors include systems for pH, dissolved oxygen, temperature, agitation, antifoam and feed addition. An understanding of these control systems and probe calibration is required. Monitoring, documenting, verification of set-point and adjustment of bioreactor parameters is necessary. Bioreactor cultures are monitored through sampling and off-line testing, on-line analysis of exhaust gases, and a computer based data collection system. Sampling, analysis and interpretation of the data is required. Organize and schedule experiments in order to ensure that work is timely and efficiently performed. Plan the use of equipment, media requirements and inoculum requirements. Often one experiment will involve the operation of several cultures at one time. Preparation of media, media supplements and buffers. Calculation of the molarities of media components. Preparation and maintenance of cell banks and viral seed stocks. Collaborate with members of Development, Research and QO in order to co-ordinate experiments, testing, and troubleshooting. Maintain accurate records of all experimental data.
Key Accountabilities and Requirements
· Scheduling experiments, assays and other activities with technical personnel
· Preparation of required reagents and equipment.
· Presentation of data, discussing process or troubleshooting information with others. Harmonious and productive interactions with other platforms, testing labs and customers.
· Reporting, SOPs, C of As, BPRs.
· Presentation of data, discussing process or troubleshooting information with others. Harmonious and productive interactions with other platforms, testing labs and customers
· Balance the needs of several customers at the same time.
· Effectively communicating process, experimental and assay methods to others, providing guidance on these methods.
Competencies Required
· Knowledge of microbiology, cell biology, virology
· Knowledge of factors that affect cell and virus growth, media requirements and interactions
· cGMP and cGLP, Good documentation practices
· Manufacture of toxicology material under cGLP and production of clinical materials in compliance with cGMP guidelines. Performance of experiments and assays which follow good documentation practices.
· Aseptic technique
· Maintain cell cultures under conditions to avoid risk of contamination. Produce clinical trial material under aseptic conditions.
· Process scale-up
· Scale-up of process from research to production scale.
· Mathematical skills and data analysis
· Buffer preparation, calculation of yields etc. Compiling reports and improving current protocols based on new experimental results.
· Computer skills including MS Word, Excel, NAIO Documentum, SAP
· Calculations on spreadsheets, reporting, drawings, SOP authoring and review, data collection and manipulation, ordering supplies and equipment maintenance and repairs.
Behavioral Competencies
· Able to operate in a team context.
· Ability to shift focus as new priorities arise.
· Establishing a collaborative/ productive working environment involving everyone in the group
· Learning new methods efficiently, seeking information from others.
· Making independent decisions about experimental parameters.
· Aptitude for highly innovative research and development.
Education/Experience
B.Sc. (Microbiology, Biology/Biochemistry,/Chemical engineering). 1-3 years previous relevant experience would be an asset. Proficiency in the use of Microsoft Office applications, SAP and electronic quality systems..
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