Job at a glance
AstraZeneca is seeking a highly motivated and experienced Scientist, Drug Product Development to support drug product development activities for lentiviral vector (LVV) programs within our Cell Therapy and Genetic Medicines portfolio. The successful candidate will contribute to the development of robust drug product formulations and processes that enable clinical advancement of ex vivo and in vivo cell and gene therapy programs.In this hands-on laboratory-based role, the Scientist will be responsible for designing, executing, analyzing, and reporting drug product development studies supporting formulation development, fill-finish processes, characterization, stability assessments, and technology transfer activities.
The position requires close collaboration with Process Development, Analytical Development, Manufacturing, Quality, Regulatory, and external partners to deliver high-quality scientific data and development packages.Key ResponsibilitiesFormulation DevelopmentDesign, execute, and document formulation development studies for LVV and other viral vector drug products.Evaluate formulation components and process conditions to improve vector stability, potency, and product quality.Generate scientific data to support selection of platform and program-specific formulations.Analyze study results and present findings to cross-functional teams.Drug Product Process DevelopmentPlan and perform laboratory and pilot-scale drug product studies supporting fill-finish process development.Support evaluation of filling processes, container closure systems, storage conditions, and shipping configurations.Execute studies related to freeze-thaw performance, hold-time assessments, and process robustness.Participate in development and optimization of drug product manufacturing processes.Characterization and Stability StudiesDesign and execute stability studies to support product development and regulatory submissions.Collaborate with Analytical Development to assess critical quality attributes, including potency, infectivity, particle characteristics, and product integrity.Interpret experimental results and provide data-driven recommendations.Support development of stability-indicating strategies and shelf-life assessments.Technology Transfer SupportSupport drug product technology transfer activities to internal manufacturing sites and external CDMOs.Generate development data and documentation required for scale-up and process transfer.Participate in troubleshooting activities during manufacturing campaigns and process implementation.Assist in development of scale-down models and comparability studies as needed.Documentation and Regulatory SupportAuthor protocols, technical reports, development summaries, risk assessments, and manufacturing support documents.Maintain accurate laboratory records in accordance with company and quality requirements.Contribute to preparation of CMC documentation and technical sections for regulatory submissions, including IND-enabling packages.Ensure activities are conducted in compliance with applicable quality systems and regulatory expectations.Cross-Functional CollaborationWork closely with Upstream and Downstream Process Development, Analytical Development, Manufacturing, Quality, and Regulatory teams to advance development programs.Communicate scientific findings clearly through written reports, presentations, and team discussions.Contribute technical expertise during project planning and development strategy discussions.Support problem-solving and investigation activities across development programs.Innovation and Continuous ImprovementStay current with emerging drug product and formulation technologies relevant to viral vectors and cell therapy products.Identify opportunities to improve laboratory workflows, experimental approaches, and development processes.Contribute to implementation of new technologies and best practices within the organization.QualificationsEducationPh.D.
in Pharmaceutical Sciences,