Lupin is comprised of a fast-growing, innovative, and robust team across manufacturing, Research and Development, and commercial divisions. These entities form the core of Lupin's U.S. business, with a significant pipeline in generics and a branded focus on women's health. Our first Research and Development facility in the US is located in Coral Springs, Florida, focusing on generic and branded inhaled and nasal drug products. Somerset, New Jersey, hosts one of fifteen global manufacturing sites and the only Lupin commercial manufacturing facility in the US, along with additional R&D teams. Lupin prides itself on being people-focused, emphasizing the impact we have on our customers rather than just financial metrics.
Responsibilities
Role Summary
Manage site IT operations in an R&D and GMP facility with multiple stakeholders, ensuring the core infrastructure in Coral Springs and Naples is operational. Establish strong relationships with business and central IT teams.
IT Infrastructure Management
Essential Duties and Responsibilities
- Oversee efficient site IT operations, including server and network monitoring, link monitoring, and end-user support services.
- Manage budgeting and tracking for IT resources.
- Identify and implement improvements in site IT operations in alignment with global standards.
- Lead site projects such as infosec initiatives, cloud migrations, data center interventions, quality monitoring, R&D applications, and physical security systems.
- Handle site contracts and licensing renewals.
- Collaborate across organization levels to enhance role effectiveness.
- Coordinate with vendors and internal teams to resolve complex issues and deploy new services.
- Conduct disaster recovery and restore drills for critical applications.
- Manage vendor relationships for plant and R&D systems.
- Track IT inventory, including hardware and software assets.
- Support site audits and ensure software license compliance.
- Maintain and update IT SOPs, ensuring compliance.
- Resolve issues related to servers, storage, patching, and backups.
Site Quality / CSV Support
Assist with quality investigations related to IT systems.Manage CSV activities and validation lifecycle.Create and maintain GMP documentation.Application Support Front End
Serve as the primary contact for application support and projects.Coordinate with corporate IT for ticket resolution.Qualifications
Education and Experience :
Masters / Bachelors in IT or related field; certifications preferred.15-20 years of overall experience, with 5-10 years in IT management roles.Knowledge of IT infrastructure and networking, including data centers, servers, firewalls, switches, Active Directory, O365, and related technologies.Experience with software licensing, compliance, and systems like SAP and Trackwise is desirable.Understanding of 21CFR Part 11 compliance in IT operations.Experience working in pharmaceutical R&D or manufacturing settings.Familiarity with GMP processes and computer system validation (CSV).Strong conflict management and team leadership skills.Hands-on knowledge of Windows OS, server OS, network protocols, virtualization technologies, and IT management tools.Additional Information
Lupin is an equal opportunity employer. Physical requirements include typical office activities, with some lifting up to 15 pounds. The role is based in a professional office environment.
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