Senior Scientist, Process Development

At AstraZeneca's Oncology R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.The Senior Scientist, Process Development leads process development activities and ensures the application of well-designed unit operations for use in the clinical manufacture of cell therapy products. You will work with colleagues in Analytical Development, Research, Manufacturing, Quality Control/Assurance, Regulatory, and other areas. This role is based in Santa Monica, CA, and reports to the Senior Director, Process Development.What you will do:Guide autologous platform and process development efforts focused on T-cell-derived cell therapies.Support technology transfer of autologous T-cell derived cell therapy processes into the development and clinical manufacturing environment.Directly support the implementation of automated end-to-end manufacturing processes, working with equipment vendors and internal resources to ensure successful outcomes.Collaborate with and participate in teams to facilitate IND-enabling, clinical Phase I/II-promoting activities.Perform data analysis, provide interpretation, and integrate results into the context of a project.Independently design strategies for implementation of scalable upstream and downstream manufacturing processes of engineered T cells.Collaborate within the project team to interpret study results and contribute to technical discussions for subsequent study design.Prepare experimental proposals, technical reports, SOPs, and manufacturing batch records.Communicate program progress and issues to management.Work collaboratively within PD group and with other groups to meet Technical Operation organization goals.Oversee associates in the execution of development activities.Potentially oversee laboratory, equipment, and facilities.Mentor staff in career development and managing development plans.Minimum Qualifications:PhD in Immunology, Biological Sciences, Biomedical Engineering, or related field with a minimum of 3 years of experience (academic experience post-graduate also considered) OR MS with a minimum of 6 years of industry experience (relevant academic experience also considered) OR a BS with a minimum of 8 years of industry experience is required.Knowledge of biology/immunology/biochemistry as applied in cell and gene therapy processes is required.Experience in autologous T-cell therapy manufacturing is required.Prior hands-on experience with automation equipment and end-to-end systems is required; expertise in their operations in both process development and manufacturing environments for cell therapies is advantageous.Knowledge of cGMP manufacturing and regulations and practical experience in GMP operations.Knowledge of statistical analysis for process development.Design and complete experiments.AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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