Neogene is seeking a highly motivated researcher to join the Process Development team as Associate Scientist, supporting and contributing to the design and execution of studies to develop and optimize clinical manufacturing processes of Neogene portfolio of engineered T cell therapies. Based in Santa Monica, CA, this role reports to the Senior Scientist, Process Development.
Essential Functions and Responsibilities Design and execute experiments to develop and optimize robust and scalable manufacturing processes for manufacture of genome engineered T cell products.
Conduct thorough characterization studies to understand process and product quality attributes for cell therapy drug product manufacturing.
Collect and analyze experimental data and generate clear and concise reports summarizing findings and recommendations. Collaborate within the project team to interpret study results and contribute to technical discussions for subsequent study design.
Collaborate closely with cross-functional teams, including research/development scientists, manufacturing personnel, and quality control, to ensure seamless technology transfer from process development to manufacturing. Effectively communicate project updates, results, and strategies to collaborators and team members.
Stay up to date with the latest scientific advancements and emerging technologies in cell therapy process development. Help evaluate and implement new technologies and methodologies to enhance process efficiency and productivity.
Maintain accurate and detailed laboratory notebooks and electronic records in compliance with company policies and regulatory requirements. Prepare and review technical documents, including standard operating procedures (SOPs), batch records, and development reports, as needed.
Work effectively in a team environment to meet project timeline and objectives.
Perform other duties as assigned.
Required Skills/Abilities At least 3 years of demonstrated hands-on experience in developing production processes for genome engineered primary cells (required) including T cells (highly preferred).
A minimum of three (3) years practical experience with Flow Cytometry.
Hands-on experience performing analytical methods typically used in the manufacture and characterization of biological products.
Proficiency with Microsoft Excel or statistical analysis software (JMP, Minitab, Prism, etc.) for analyzing and presenting data.
Working understanding of US/EU regulatory requirements and working knowledge of cGMPs.
Ability to think critically, analytically and have demonstrated troubleshooting and problem-solving skills based on deductive reasoning.
Ability to design and implement experiments with minimal technical supervision.
Strong organizational and time management skills, with the ability to prioritize and manage multiple projects simultaneously.
PhD degree in Immunology, Cell Biology, Molecular biology, Bioengineering, or relevant degrees or similar MS degree with 3+ years proven experience or similar BS degree with 5+ years relevant experience within the pharmaceutical or biotech industries.
Are you ready to make a real-life difference to patients? Join us at AstraZeneca where we have built an unrivaled reputation in Quality, through our 'Total Quality' culture that takes us beyond pure compliance. Apply now!
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.
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