Cell Culture Specialist

Cell culture Specialist; Skills to support Upstream process development, Process Scale up, Process characterization for mAb manufacturing. Develop and establish scalable and robust processes for meeting desired product yield and quality Assess risk and actively plan for risk mitigation strategies during process development and scale up Collaboration with cross functional teams within RND & other departments like manufacturing, quality control, quality assurance for technical discussions related to process development, technology transfer and process improvement. Participate in technology transfer activities, coordination with program management and cross functional teams to deliver on program timelines. Provide appropriate support for regulatory dossier, filing and audits. Scientific awareness on the latests advancements in science and technology, bioprocessing. Possess statistical knowledge in using appropriate QbD and DOE concepts into upstream development, Ensure thorough data analysis for assessing upstream data and for supporting technical decisions. Recording and reviewing of raw data in accordance to GDP principles. Prepare work presentations, write technical documents (process protocols, technical/development reports), procedures (SOP’s/IOP’s/EOP’s) Coordinate within and across team for smooth functioning of lab activities. Special requirement: The candidate must possess technical expertise in ONE of the below areas in addition to the above: Omics technologies – Metabolomics, Metabolic Flux Analysis Bioprocess modeling – Metabolic modeling, process modeling, digital twin for bioreactor or cells CFD – Computational fluid dynamics to better understand and simulate bioreactor mixing Educational Requirements : Only Recent PhD Graduates will be considered for the role.

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