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 cross-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 cross‑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 contribute 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 adherence to cGMP/ATMP requirements and data integrity principles (ALCOA+).
• Training & Knowledge Transfer: Deliver operator training on critical process steps or process changes; contribute to lessons-learned, playbooks, and best practices 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
• Contribute to technology transfer packages (process descriptions, URS inputs, BOMs, risk assessments), implement process changes, coordinate execution of engineering runs and comparability/bridging studies, author technical reports
• Translate process characterization outputs from development into manufacturing controls, and draft sections of PPQ protocols/reports
• Provide on‑the‑floor technical support during scale‑up, engineering runs, PPQ batches, and commercial manufacturing campaigns (including off‑shift support when required).
Cross‑Functional Collaboration
• Position serves as primary interface between site Manufacturing, site Quality, site Supply Chain, and global functions of Process Development and CMC regulatory
• Support lifecycle management for cell therapy processes, including continuous improvement initiatives and post-approval changes