Senior Process Engineer, Manufacturing, Science, and Technology (MSAT) Cell Therapy

Senior Process Engineer, Manufacturing Sciences & Technology, Cell Therapy:     Location: AstraZeneca, Rockville, MD   Travel: Up to 15% domestic and international travel required  Position Summary   We are seeking an experienced Senior Process Engineer to join our Manufacturing Sciences & Technology (MS&T) function as a member of the site-based MS&T team at AstraZeneca’s Rockville, MD cell therapy manufacturing facility.   This position focuses on ensuring robust, compliant, and cost-effective manufacturing of clinical and commercial cell therapy products.   Responsibilities include leading on-the-floor / hands-on technical support, developing technical instructions, procedures, and operator training content, performing data analysis and process performance trending, leading complex deviation investigations, driving implementation of CAPAs and continuous improvement through change controls, and giving to validation and regulatory work. These responsibilities will be exercised through the scope of supporting technology transfers, clinical manufacturing, site readiness, process validation/PPQ, commercial manufacture readiness, and product lifecycle management activities.  The ideal candidate brings hands-on experience with cell therapy unit operations through previous experience in process development and/or manufacturing, as well as expertise in technology transfer. Experience with process validation and commercialization activities is desired. This position will report to Director, MS&T, Cell Therapy Development and Operations.  Key Responsibilities   Site manufacturing support   • Process Execution Support: Provide day-to-day technical support for cell therapy manufacturing, including on-the-floor support for critical campaigns (including occasional off-shift support where required)  • Operations Support: Represent Site MS&T function at site operational tier meetings, providing collaborative inputs that drive site activities  • Data trending and analysis: Maintain manufacturing data tracking system and control charts, perform trend analyses, identify signals, and drive timely signal-to-action with clear documentation and multi-functional alignment.  • Process performance monitoring: Conduct batch record review, deviation assessment, and data trending to ensure robustness of cell therapy manufacturing processes.  • Deviation/CAPA Support: Lead or co-lead technical investigations for deviations and process excursions, perform root cause analysis, develop and implement CAPAs with appropriate data.  • Continuous improvements: Identify, justify, and implement continuous improvements by shepherding changes through multi-functional change controls with appropriate risk assessments and comparability.  • Raw materials: Support qualification of critical materials (e.g., cytokines, viral vector, single-use assemblies) and assess impact of raw material changes, and supply to second-source strategies  • Automation: Partner with automation/digital manufacturing teams to implement electronic batch record improvements  • Documentation & GMP Compliance: Author and revise batch records, SOPs, and technical reports; protocols, summary reports, ensure alignment to cGMP/ATMP requirements and data integrity principles (ALCOA+).  • Training & Knowledge Transfer: Deliver operator training on critical process steps or process changes; chip in to lessons-learned, playbooks, and guidelines across sites.  • Regulatory Contributions: Draft and review CMC sections (Module 3) response to agency question, support health authority and internal audits/inspections.  Technology Transfer & Process Validation   • Draft and review risk assessments and comparability study design  • Chip in to technology transfer packages (process descriptions, URS inputs, BOMs,