Description

Lead IT initiatives for cell therapy digital platforms, overseeing manufacturing, orchestration, integration, and compliance in regulated pharmaceutical environments.

This role is on-site.

Responsibilities

• Manage end-to-end IT programs including MES, LIMS, SAP integrations, and scheduler systems.
• Develop and execute Computer System Validation (CSV) strategies, embedding GxP requirements early in design.
• Ensure platform readiness for BLA submissions and represent Digital in regulatory audits and inspections.
• Drive cross-functional alignment between Digital, Engineering, Quality, Regulatory, and Manufacturing teams.
• Produce and maintain CSV artifacts such as URS, risk assessments, test protocols, and trace matrices.

Required Skills

• 15+ years of IT experience with 7+ years in technical program management.
• Deep expertise in US pharma regulations, GxP, 21 CFR Part 11, and Annex 11.
• Experience in Drug Manufacturing, Cell Therapy, or CAR-T environments.
• Knowledge of digital manufacturing systems: MES, LIMS, SAP, and Control systems.
• Proficiency in React JS, Python, Java, and Camunda BPM.
• Strong background in SQL, R, and data platforms like Snowflake, Azure Synapse, or Databricks.
• Familiarity with AWS cloud ecosystems and RESTful API integration architectures.

Preferred Skills

• Experience with mINT Engine, Scheduler, or Control Tower orchestration platforms.
• Background in vendor management and complex project scope delivery.

Key Skills

Education

Any Graduate