Pharma IT TPM: Cell Therapy & Digital Platforms

Artifintech; New Jersey; Vor Ort; USD 83.000 - 165.000; Vollzeit

Zusammenfassung

ARTIFICIAL INTELLIGENCE TECHNOLOGIES LLC in New Jersey seeks an IT Technical Program Manager (Java/Pharma Domain) to lead cell therapy digital platforms. You will orchestrate IT initiatives across MES, LIMS, SAP, and scheduling systems in a regulated pharma setting.

You will coordinate with Digital, Engineering, Quality, Regulatory, QA, and Manufacturing teams, and drive validation, CSV, and regulatory readiness for BLA submissions. 12+ month extension opportunities apply.

Qualifikationen

• 15-17+ years of IT experience with 7+ years in technical program management in US pharma.
• Deep experience in cell therapy, drug manufacturing and US pharma regulations.
• Experience with MES, LIMS, SAP and scheduling systems; strong vendor management.

Aufgaben

• Lead and oversee IT initiatives supporting cell therapy digital platforms within regulatory pharma environments.
• Coordinate with Digital, Engineering, Quality, Regulatory, QA and Manufacturing teams.
• Develop validation strategy and execute CSV planning across complex digital systems.
• Embed GxP (21 CFR Part 11, Annex 11) requirements early during design.
• Ensure platforms are inspection-ready for regulatory submissions and manufacturing transitions.

Kenntnisse

Program leadership

Cross-functional leadership

Communication

Regulatory awareness

Vendor management

Technical design

GxP knowledge

CSV planning

Stakeholder management

Tools

MES

LIMS

SAP

Scheduler

Control systems

System integration

Jobbeschreibung

ARTIFICIAL INTELLIGENCE TECHNOLOGIES LLC in New Jersey seeks an IT Technical Program Manager (Java/Pharma Domain) to lead cell therapy digital platforms. You will orchestrate IT initiatives across MES, LIMS, SAP, and scheduling systems in a regulated pharma setting.

You will coordinate with Digital, Engineering, Quality, Regulatory, QA, and Manufacturing teams, and drive validation, CSV, and regulatory readiness for BLA submissions. 12+ month extension opportunities apply.