Description

Role Overview: Lead and oversee IT initiatives supporting cell therapy digital platforms that drive manufacturing, orchestration, integration, and compliance within regulated pharmaceutical environments—spanning vendor systems such as MES, LIMS, SAP, and scheduling systems. 

Key Responsibilities:

• Overall 15-17+ years of IT experience and  7+year of experience in technical program management with deep experience in US pharma, Drug Manufacturing, Cell Therapy and US pharma regulations.
• Cross‑Functional Program Leadership
• Manage end-to-end IT programs (e.g., MES/LIMS/SAP integrations, scheduler systems, orchestration platforms).
• Coordinate with Digital, Engineering, Quality, Regulatory, QA, and Manufacturing teams.
• Strong knowledge of GxP regulations, validation lifecycle, and digital manufacturing system landscapes.
• Experience with MES, LIMS, SAP, Scheduler, Control systems, integration architectures.
• Experience in personalized or cell therapy manufacturing environments.
• Familiarity with digital validation frameworks in CAR-T and related cell therapy platforms.
• Computer System Validation (CSV)
• Develop validation strategy and execute CSV planning across complex digital systems.
• Embed GxP (21 CFR Part 11, Annex 11) requirements early during design.
• Regulatory Readiness & Inspection Support
• Ensure platforms are inspection-ready for BLA submissions and manufacturing transitions.
• Represent Digital in regulatory audits and inspections.
• Technical and Architectural Oversight
• Engage in technical design/architecture discussions to de-risk validation.
• Ensure integration readiness across systems (e.g., mINT Engine, Scheduler, Control Tower).
• Validation Deliverables Management
• Develop/maintain CSV artifacts: plans, risk assessments, URS, protocols, test scripts, trace matrices, validation reports
• Business Engagement & Leadership
• Able to drive cross-functional alignment and clear communication across scientific, operational, IT, and QA/regulatory teams.
• Capable of managing vendors, delivering on complex project scopes, milestones, timelines.

Required Technical Expertise:

• Programming & Frameworks: React JS, Python, Java, Camunda BPM.
• Data & Analytics: SQL, Python, R; Snowflake, Azure Synapse, Databricks;
• Cloud Ecosystems: AWS,
• Integration: RESTful APIs, Webmethods

Key Skills

Education

Any Graduate