Cell Culture Specialist

As a Cell Culture Specialist, you will play a key role in supporting Upstream process development, Process Scale up, and Process characterization for mAb manufacturing. Your responsibilities will include: - Developing and establishing scalable and robust processes to meet desired product yield and quality. - Assessing risks and actively planning for risk mitigation strategies during process development and scale up. - Collaborating with cross-functional teams within RND and other departments like manufacturing, quality control, and quality assurance for technical discussions related to process development, technology transfer, and process improvement. - Participating in technology transfer activities, coordinating with program management and cross-functional teams to meet program timelines. - Providing appropriate support for regulatory dossier filing and audits. - Staying updated on the latest advancements in science and technology, particularly in bioprocessing, and possessing statistical knowledge to incorporate appropriate QbD and DOE concepts into upstream development. - Ensuring thorough data analysis to assess upstream data and support technical decisions. - Recording and reviewing raw data in accordance with GDP principles. - Preparing work presentations, writing technical documents (such as process protocols, technical/development reports), and procedures (SOPs/IOPs/EOPs). - Coordinating within and across teams to ensure the smooth functioning of lab activities. Additionally, the ideal candidate must possess technical expertise in ONE of the following areas: - 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.,