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3 days ago
- Support upstream process development, scale-up, and characterization for monoclonal antibody manufacturing.
- Develop and establish scalable and robust processes for desired product yield and quality.
- Assess risk and plan mitigation strategies during process development and scale-up.
- Work with cross-functional teams in R&D, manufacturing, quality control, and quality assurance.
- Participate in technology transfer activities and program management.
- Stay updated on the latest advancements in bioprocessing and science.
- Apply statistical knowledge using QbD and DOE concepts.
- Technical expertise in one of the following areas:
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- Omic technologies (metabolomics, metabolic flux analysis)
- Bioprocess modeling (metabolic modeling, digital twin)
- Computational fluid dynamics (CFD) for bioreactor mixing
- Support Upstream Process Development, Scale-up, and Characterization for Monoclonal Antibody Manufacturing by collaborating with R&D, manufacturing, and quality teams to design and implement effective process workflows, ensuring compliance with relevant regulations and industry standards.
- Develop and Establish Scalable and Robust Processes for Desired Product Yield and Quality through application of advanced analytical techniques, such as HPLC, GC-MS, and PCR, to identify key performance indicators (KPIs) and optimize process conditions to achieve target yields and product quality.
- Assess Risk and Plan Mitigation Strategies During Process Development and Scale-up to mitigate potential risks associated with process changes, ensuring that necessary controls are in place to maintain product integrity and ensure smooth transition to commercial-scale operations.
As a Cell Culture Specialist, you will work closely with cross-functional teams to develop and implement cutting-edge bioprocessing solutions, applying your expertise in omic technologies, bioprocess modeling, or computational fluid dynamics to drive innovation and improve product quality. To succeed in this role, you should have a strong background in cell culture, biotechnology, and scientific computing, with excellent problem-solving skills and ability to collaborate effectively with colleagues from diverse backgrounds.
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