Description

Lead and oversee IT initiatives supporting cell therapy digital platforms that drive manufacturing, orchestration, integration, and compliance within regulated pharmaceutical environments.

This role is on-site.

Responsibilities

• Manage end-to-end IT programs including MES, LIMS, SAP integrations, and scheduler systems.
• Coordinate with Digital, Engineering, Quality, Regulatory, QA, and Manufacturing teams to align technical deliverables.
• Develop and execute Computer System Validation (CSV) strategies, ensuring GxP (21 CFR Part 11, Annex 11) requirements are embedded early.
• Represent Digital in regulatory audits and inspections, ensuring platforms are inspection-ready for BLA submissions.
• Maintain CSV artifacts including plans, risk assessments, URS, protocols, test scripts, and trace matrices.

Required Skills

• 15-17+ years of IT experience with 7+ years in technical program management.
• Deep experience in US pharma, Drug Manufacturing, Cell Therapy, and US pharma regulations.
• Strong knowledge of GxP regulations, validation lifecycle, and digital manufacturing system landscapes.
• Experience with MES, LIMS, SAP, Scheduler, Control systems, and integration architectures.
• Proficiency in React JS, Python, Java, and Camunda BPM.
• Strong data and analytics skills using SQL, Python, R, Snowflake, Azure Synapse, and Databricks.
• Cloud ecosystem experience with AWS and integration via RESTful APIs and Webmethods.

Preferred Skills

• Experience in personalized or cell therapy manufacturing environments.
• Familiarity with digital validation frameworks in CAR-T and related cell therapy platforms.

Key Skills

Education

Any Graduate