Description

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

Responsibilities

• Manage end-to-end IT programs, including MES/LIMS/SAP integrations, scheduler systems, and orchestration platforms.
• Develop and maintain Computer System Validation (CSV) artifacts such as plans, risk assessments, URS, protocols, and trace matrices.
• Embed GxP requirements (21 CFR Part 11, Annex 11) early during the design of complex digital systems.
• Ensure platforms are inspection-ready for BLA submissions and manufacturing transitions, representing Digital in audits.
• Engage in technical design discussions to de-risk validation and ensure integration readiness across systems.

Required Skills

• 7+ years of experience in technical program management within US pharma or Drug Manufacturing.
• 15+ years of overall IT experience, with deep exposure to Cell Therapy and US pharma regulations.
• Experience managing systems like MES, LIMS, SAP, and scheduling systems in personalized therapy environments.
• Strong knowledge of GxP regulations, validation lifecycle, and digital manufacturing system landscapes.
• Proficiency with integration architectures, including RESTful APIs and Webmethods.
• Experience with cloud ecosystems, specifically AWS.
• Familiarity with programming/frameworks such as Python, Java, and Camunda BPM.
• Experience with data platforms including Snowflake, Azure Synapse, and Databricks.
• Competency in SQL and R for data analysis.

Key Skills

Education

Any Graduate