Description

You will lead and oversee IT initiatives for cell therapy digital platforms supporting manufacturing, orchestration, integration, and compliance in regulated pharmaceutical environments.

Responsibilities

• Manage end-to-end IT programs, including MES/LIMS/SAP integrations and scheduler systems.
• Develop and maintain CSV artifacts: plans, risk assessments, URS, protocols, test scripts, and validation reports.
• Embed GxP (21 CFR Part 11, Annex 11) requirements early in the design phase across complex digital systems.
• Ensure platforms are inspection-ready for BLA submissions and manufacturing transitions.
• Drive cross-functional alignment across scientific, operational, IT, and QA/regulatory teams while managing vendors.

Required Skills

• 15+ years of IT experience, with 7+ years in technical program management within US pharma.
• Deep experience in Drug Manufacturing, Cell Therapy, and US pharma regulations (GxP).
• Proficiency with MES, LIMS, SAP, Scheduler, and Control systems integration architectures.
• Experience with digital validation frameworks in CAR-T and cell therapy platforms.
• Knowledge of programming/frameworks including React JS, Python, Java, and Camunda BPM.
• Experience with SQL, R, Snowflake, Azure Synapse, and Databricks.
• Familiarity with integration patterns using RESTful APIs and Webmethods.

Key Skills

Education

Any Graduate