Associate Director, Cell Therapy Robustness Process Monitoring Systems Lead

Role Summary

Associate Director, Cell Therapy Robustness Process Monitoring Systems Lead. Responsible for the establishment and maintenance of systems to support process data trending programs for commercial and late-stage clinical products across the cell therapy network. Leads the statistical process control program and continued process verification, representing the process monitoring and investigations function in cross-functional forums to ensure consistent data monitoring and transparency.

Responsibilities

• Create and maintain business tools and standard operating procedures for DP SPC and CPV programs, establishing standard work for all manufacturing sites and seamless cross-site data integration to enable root cause analysis, CAPA identification, and documentation.
• Serve as the interface between sites, product teams, and laboratories to ensure consistent data monitoring activities.
• In partnership with product and site teams, execute end-to-end product robustness reviews that integrate DP, analytical, and vector monitoring programs.
• Promote innovative and efficient approaches to SPC and CPV based on risk-based elements and considerations unique to cell therapy production.
• Manage complex cross-functional projects/programs using appropriate project management techniques and tools.
• Train end users on process robustness systems and procedures.

Qualifications

• Required: Bachelor's degree or equivalent in a relevant discipline with at least 10 years of relevant experience (Master's preferred). Time spent in advanced degree programs may be considered as equivalent experience.
• Expertise in statistical data analysis and experience with statistical programs (e.g., Discoverant, JMP).
• Ability to program using data science languages such as Python, R (a plus).
• Expert understanding of cGMP regulations and related business/documentation processes.
• Highly proficient in technical writing and presentations; experience generating formal reports and publications.
• Proficient in project and portfolio management skills.

Skills

• Statistical data analysis
• SPC and CPV program management
• Cross-functional collaboration
• Technical writing and presentations
• Project management

Education

• Bachelor's degree or equivalent in a relevant discipline (Master's preferred)

Additional Requirements

• On-site/field flexibility as required by role alignment (site-essential, hybrid, or field-based).
• Ability to travel as needed to collaborate across sites.
• Compliance with applicable vaccine and health guidelines as required by role and location.