- 22-Oct-2014 to 22-Oct-2014 (EST)
- Mississauga, ON, CAN
Process Development Team members developing and upscaling manufacturing processes involving culture and purification of virus and protein for use in human diagnostics.
Our Process Development Associates have a variety of skills and enjoy opportunities to acquire new ones. Team members work in focused collaborative teams that will make a positive impact on company performance.
The current available positions will involve work in culture, purification and testing of materials generated in mammalian and viral cultures. Candidates are expected to contribute to project completion in at least 2 of the 3 technical areas of work based on their prior experience.
Microbix Biosystems is a fast growing biotechnology company based in Mississauga.
Founded in 1988 as a producer of infectious disease antigens, primarily for the diagnostics market, the Company invests in the virology business to build capacity and develop new products to address emerging market opportunities, while enhancing manufacturing and laboratory capabilities and technologies.
Building on expertise in virology and protein biochemistry, the Company developed a pipeline of selected biological technologies including VIRUSMAX (Influenza Virus Yield Enhancement Technology), LumiSort™ (Semen Sexing Technology) and the thrombolytic drug, Kinlytic® (Urokinase).
Our emerging products take aim at large market opportunities. With Microbix' core competencies in the Diagnostics business, including cell culture, molecular biology, and GMP quality system, these new products build on Microbix' strength.
- Perform culture of mammalian cells and virus in a number of culture systems including flasks, roller bottles and bioreactors.
- Perform experimentation to improve cell health and productivity using Team established strategies such as medium optimization, modification of stir rates and gas flows.
- Execute studies to generate optimal yield of virus or viral protein.
- Generate culture feedstock to support downstream purification development.
- Work with equipment for centrifugation, filtration (including TFF) and chromatography for purification.
- Prepare buffers and other reagents according to written procedures.
- Set up and cleaning of equipment from lab to process scale.
- Test materials generated from culture and purification development experimentation. Primary test methods include protein determination, PCR and ELISA.
- Testing work includes experimentation to develop new test methods for new products using new and existing testing strategies.
- Incumbent will work with a project team to enhance project objectives and project execution plans.
- Prepare or edit standard operating procedures, test methods, batch records, protocols and reports.
- Perform data analysis and propose conclusions to the Team including project Scientists. Suggest next steps based on those analyses.
- Work on development in accordance with Company procedures and requirement of regulatory agencies in a GMP environment.
- Undergraduate degree in microbiology, biochemical or chemical engineering, biotechnology, protein chemistry, or a related field as a minimum with appropriate relevant experience
- Minimum of 3 years of experience in process development and/or manufacturing in a GMP environment.
- Hands-on experience with:
- Mammalian cell and virus culture in stationary and stirred equipment.
- Downstream processing procedures and equipment including filtration, TFF, chromatography, virus inactivation technology. Ability to operate Unicorn based equipment such as AKTA FPLC is an asset.
- Performing qualitative and quantitative assays for in-process control or product release.
- Effective in verbal and written communication providing information to the project team, project scientists and other involved departments.
- Knowledge of ICH and other regulatory requirements for process development and ability to review or generate plans, protocols and reports in keeping with those requirements.
- Ability to proactively identify issues and identify solutions in a collaborative environment.
- Experience with validation of equipment and processes would be an asset.
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