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About Us

Welcome to ANI Pharmaceuticals, where we are dedicated to improving and enhancing patients' lives through the manufacturing and distribution of high-quality pharmaceutical products. With a diverse portfolio of generic and branded pharmaceuticals, ANI is a trusted partner for healthcare providers, pharmacists, and patients alike, offering accessible products across a wide range of therapeutic areas to support communities globally. At ANI Pharmaceuticals, there are opportunities to contribute to our purpose every day. We value authenticity, knowledge, and hard work, and our culture empowers every employee to succeed and apply their full potential in a positive environment.

About the Role

The Manufacturing IT Manager is responsible for overseeing all manufacturing and shop-floor IT systems within a GMP-regulated pharmaceutical environment. This role ensures uptime, compliance, and integration across Production, Packaging, Serialization, Quality, Engineering, Supply Chain, Labs, and EHS. The leader will support machine-level operations, drive digital transformation, and ensure strict adherence to GxP and data integrity requirements. This role spans all ANI Pharmaceuticals manufacturing sites across Minnesota, Wisconsin, and New Jersey.

Responsibilities

1. Manufacturing Systems & Shop-Floor Technology

• Own and evolve a portfolio of critical manufacturing systems, MES, ERP integrations, LIMS, QMS, data historians, SCADA/DCS, ensuring they are stable, validated, and business-enabling.

• Provide hands-on line support for production and packaging equipment: HMIs, scanners, printers, weigh scales, robotics, vision systems, batch controllers, and line integration technology.

• Drive real-time troubleshooting on the production floor; build escalation frameworks that get issues resolved fast and root causes documented properly.

• Serve as the accountable IT owner for all manufacturing system change control and lifecycle planning.

2. Serialization & Track-and-Trace

• Lead IT oversight for end-to-end serialization across all packaging lines, from equipment configuration through regulatory submission.

• Manage Level 2-4 serialization systems (Antares, Systech, Tracelink, Optel) and ensure seamless integration with ERP, Quality, and regulatory data flows.

• Own DSCSA, EU FMD, and global serialization compliance, partnering closely with Quality and Supply Chain to maintain audit readiness and full traceability.

• Proactively identify serialization risks; communicate them clearly to leadership and mobilize cross-functional response before they become audit findings.

3. GMP Compliance, CSV & Data Integrity

• Set and sustain the standard for GMP, cGMP, and GAMP 5 compliance across all manufacturing and lab systems.

• Lead Computer System Validation (CSV) end-to-end: URS, FS, DS, IQ/OQ/PQ, periodic reviews, and change control, reducing cycle time without compromising quality.

• Uphold ALCOA+ principles for data integrity and electronic records, maintaining inspection readiness across all sites.

• Act as a trusted voice in Quality forums, capable of explaining technical risk in plain language and proposing pragmatic, compliant solutions.

4. Cross-Functional Leadership & Stakeholder Partnership

• Operate as the primary IT executive partner across all manufacturing functions, building relationships grounded in trust, transparency, and delivery.

• Lead business engagement forums, prioritization councils, and change control boards, facilitating alignment across functions with competing priorities and timelines.

• Translate operational pain points into digital roadmaps and executable programs of work; communicate progress, risks, and decisions for both plant-floor supervisors and the C-suite.

• Proactively surface cross-functional dependencies, resolve conflicts early, and ensure no critical initiative stalls because stakeholders aren't aligned.

• Represent IT in regulatory inspections, customer audits, and internal quality reviews.

5. Digital Transformation & Continuous Improvement

• Drive Pharma 4.0 initiatives: paperless batch records, digital logbooks, automated reporting, IoT sensors, machine connectivity, and AI-based intelligence on the shop floor.

• Lead system upgrades, migrations, and integrations for manufacturing and packaging platforms.

• Vendor & Contract Management: manage vendor relationships, contracts, SLAs, and performance reviews.

• Identify and champion continuous improvement opportunities; build a culture where the team doesn't just support the status quo but actively makes it better.

• Benchmark against pharma industry best practices and bring external perspective and innovative thinking into ANI's manufacturing IT strategy.

6. OT Infrastructure & Cybersecurity

• Oversee plant networks, servers, manufacturing VLANs, and segregated OT environments.

• Ensure cybersecurity compliance for connected manufacturing equipment, SCADA systems, and serialization infrastructure; own OT/IT segmentation for the manufacturing environment.

• Align with corporate IT on patching cadence, backups, disaster recovery, and user access governance, acting as the bridge between OT realities and corporate security policy.

7. Operational Support & Incident Management

• Provide real-time, decisive support during batch execution failures, packaging line downtime, serialization events, and lab workflow disruptions.

• Build and maintain a structured 24/7 on-call rotation model to ensure coverage across all sites; ensure escalation paths are clear, response SLAs are met, and every incident drives a learning.

• Establish post-incident review discipline, RCA, corrective action, and closure.

8. Team Leadership & Organizational Development

• Lead, inspire, and develop a team of shopfloor/OT analysts, automation support engineers, and system administrators across the North America region.

• Build individual capability roadmaps for team members, investing in GMP systems knowledge, shop-floor automation, integration expertise, and CSV skills.

• Set high standards and create an environment where people feel safe raising issues early, taking calculated risks, and continuously learning.

• Foster a culture of compliance and urgency, modeling and recognizing behaviors the team should emulate.

• Recruit and retain top talent, secure the resources needed to achieve strategic objectives, and drive succession planning to support long-term organizational growth and continuity.

Skills/Competencies

• Demonstrates strong technical leadership, applying a disciplined, data-driven approach to problem-solving and investigations.

Qualifications / Requirements

• Bachelor's degree in Information Technology, Supply Chain, Regulatory Affairs, or Manufacturing Engineering; advanced degree a plus.

• 10+ years of experience in pharmaceutical serialization, Tracelink, or EPCIS-based systems.

• 4 years in a leadership role managing cross-functional programs and teams.

• Deep expertise across MES, ERP (SAP preferred), LIMS, QMS, SCADA/DCS, and serialization platforms with shop-floor integration technologies.

• Proven GMP compliance credentials: hands-on CSV experience (GAMP 5, 21 CFR Part 11, Annex 11, ALCOA+) and a track record of sustaining compliance across multiple sites and audits.

• Travel: up to 30% between sites (MN, NJ, WI).

Compensation & Benefits

The base salary (hourly) range for this position is $150,000-$175,000; the exact salary depends on various factors such as experience, skills, education, location, competencies and industry-specific knowledge. Only to be included if position is STI and/or LTI bonus eligible: In addition to base salary, this position is eligible for participation in a competitive short-term (and long-term) incentive program based on performance and company results.

ANI Pharmaceuticals offers a variety of benefits to eligible employees, including health insurance coverage, life and disability insurance, retirement savings plans, paid leave programs, paid holidays and paid time off. Many of these benefits are subsidized or fully paid for by the company.