Senior Process Engineer, Manufacturing Sciences & Technology, Cell Therapy

Senior Process Engineer supporting clinical and commercial cell therapy manufacturing at AstraZeneca's Tarzana facility. Role encompasses on-site technical leadership, process validation, deviation investigations, continuous improvement, and regulatory compliance across technology transfer and commercial readiness initiatives.

Responsibilities

• Provide on-the-floor technical support for cell therapy manufacturing campaigns, including off-shift support when required
• Lead deviation and CAPA investigations, perform root cause analyses, and implement corrective actions with appropriate documentation
• Maintain manufacturing data tracking systems, perform trend analyses, and drive signal-to-action for process performance monitoring
• Author and revise batch records, SOPs, technical reports, and regulatory submissions ensuring cGMP and ATMP compliance
• Support technology transfer activities including risk assessments, engineering runs, PPQ execution, and comparability study coordination

Requirements

• Hands-on expertise in cell therapy unit operations and processing equipment
• Experience executing or reviewing batch records, managing deviations, and conducting investigations in GMP environments
• Proficiency with statistical analysis including univariate, multivariate analysis, and control charts
• Strong technical writing and verbal communication skills
• Cross-functional collaboration and problem-solving abilities
• Experience with process validation and commercial readiness activities (preferred)

Compensation: $103,286.40–$154,929.60 base