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 AnalysisBioprocess modeling – Metabolic modeling, process modeling, digital twin for bioreactor or cellsCFD – Computational fluid dynamics to better understand and simulate bioreactor mixingEducational Requirements :
Only Recent PhD Graduates will be considered for the role.