Senior Manufacturing IT & Digital Operations Leader

ANI Pharmaceuticals; Princeton (NJ); Hybrid; USD 150,000 - 175,000; Full time

Benefits offered by this job

Health insurance

Life and disability insurance

Retirement savings plans

Paid leave and holidays

Paid time off

Job summary

ANI Pharmaceuticals in Princeton, NJ, is seeking a Senior Manager, Manufacturing IT Manager & Digital Operations to lead shop-floor IT systems within a GMP environment. This hybrid role oversees manufacturing IT across multiple sites and drives digital transformation across production, packaging, and quality.

The ideal candidate has 10+ years in pharma serialization and 4+ years in leadership, with deep expertise in MES, ERP (SAP preferred), LIMS, QMS, SCADA/DCS, and serialization platforms.

Qualifications

• Bachelor’s degree in IT or related field; 10+ years in pharma serialization or EPCIS-based systems.
• 10+ years in pharmaceutical serialization, Tracelink, or EPCIS-based systems.
• 4 years in a leadership role managing cross-functional programs.
• Deep expertise across MES, ERP (SAP preferred), LIMS, QMS, SCADA/DCS.

Responsibilities

• Lead IT executive partner across all manufacturing functions with a focus on delivery.
• Oversee serialization compliance and lifecycle management for packaging lines.
• Drive GMP, CSV, data integrity, and 21 CFR Part 11 compliance across sites.
• Manage vendor relationships, SLAs, and cross-functional program governance.
• Lead Pharma 4.0 initiatives and responsible for system upgrades and integrations.

Skills

Leadership

Cross-functional collaboration

Regulatory compliance

GxP awareness

Education

Bachelor’s degree in Information Technology / Manufacturing

Tools

SAP ERP

Tracelink

EPCIS

LIMS

QMS

SCADA/DCS

Job description

ANI Pharmaceuticals in Princeton, NJ, is seeking a Senior Manager, Manufacturing IT Manager & Digital Operations to lead shop-floor IT systems within a GMP environment. This hybrid role oversees manufacturing IT across multiple sites and drives digital transformation across production, packaging, and quality.

The ideal candidate has 10+ years in pharma serialization and 4+ years in leadership, with deep expertise in MES, ERP (SAP preferred), LIMS, QMS, SCADA/DCS, and serialization platforms.