Senior Director Infrastructure and Operations

Overview

The Sr Director of Infrastructure and Operations, reporting into the VP of Information Technology, is a key leadership role at Celldex Therapeutics responsible for overseeing enterprise IT infrastructure, cloud strategy, and operational excellence. This role ensures the scalability, security, and compliance of IT systems while driving digital transformation and innovation to support R&D, Clinical, Manufacturing Operations and Commercialization functions. The ideal candidate has 15 years of IT leadership experience and a strong background in GXP compliant IT environments, cloud computing and IT service management. They will lead a cross functional team responsible for networking, data centers, cloud platforms, cybersecurity, and IT operations, ensuring high availability and regulatory compliance. This position requires strategic vision, technical expertise, and the ability to collaborate with business teams to help delivery on Celldex strategy and goals.  

Responsibilities

Infrastructure Strategy & Leadership

• Define and execute the IT infrastructure and operations strategy aligned with business objectives.
• Lead the design implementation and management of enterprise wide IT systems networks and cloud solutions.
• Evaluate emerging technologies to enhance scalability security and performance.

IT operations and service management

• Oversee day-to-day IT operations ensuring high availability performance and reliability.
• Implement and optimize IT service management processes such as incident problem and change management.
• Dr. automation and efficiency improvements in IT operations.

Security and compliance

• Ensure IT infrastructure is compliant with industry standards.
•  Work closely with VP of IT and security teams to enforce security best practices and disaster recovery plans

Cloud & Digital Transformation

• Lead cloud migration initiatives (AWS, Azure).
• Oversee hybrid cloud environments and optimize infrastructure for cost and performance.
• Implement DevOps and site reliability engineering best practices.

Regulatory Compliance & Data Integrity

• Ensure IT infrastructure and operations comply with GxP, FDA 21 CFR part 11, HIPAA, and ISO 13485 requirements.
• Implement validated systems to support electronic records and electronic signatures.
• Work closely with QA regulatory and compliance teams to align its practices with industry regulations.
• Support vendor qualifications and audits for IT systems used in GxP environments.
• Maintain comprehensive documentation and SOPs for IT processes to meet audit requirements.

Financial & Vendor Management

• Manage multimillion dollar IT budgets ensuring cost effective solutions.
• Negotiate contracts with vendors service providers and cloud providers.
• Optimized software hardware and licensing expenditures.

Team leadership and organizational development

• Lead and mentor large geographically distributed IT teams.
• Foster a culture of continuous improvement innovation and collaboration.
• Develop talent pipelines and succession plans for key IT leadership roles.

Qualifications

• Bachelor degree (or experience) in Computer Science, Information Technology, or related field.
• Relevant certifications (preferred but not required):
  • ITIL (Information Technology Infrastructure Library)
  • CISSP (Certified Information Systems Security Professional)
  • AWS or Azure Architect certifications

• 15 plus years of IT experience with at least 7 to 10 years in leadership roles overseeing IT infrastructure and operations.

• Strong experience in regulated environments (Pharmaceutical, Biotech, Clinical or Medical Device industries).

• Deep understanding of GXP, FDA 21 CFR part 11, HIPAA, GDPR, and ISO 27001 compliance.

• Proven track record managing enterprise IT infrastructure including data centers, cloud, networking, and cyber security

• Experience leading multi-site and global IT operations in a pharmaceutical R&D, manufacturing, or clinical setting.

• Demonstrated ability to lead digital transformation initiatives including cloud migrations, automation, and IT operations.

• Strong vendor management skills including contract negotiations with cloud providers, IT service partners, and managed services organizations.

• Strategic thinking - ability to align IT infrastructure and operations with business and regulatory needs.

• Leadership and team development - experience managing large, distributed IT teams and third party providers.

• Collaboration and communication - ability to work across R&D, clinical, manufacturing, regulatory, and commercial teams.

• Problem solving - strong analytical skills for troubleshooting complex IT and operational challenges.

• Budget and financial management - experience overseeing multimillion dollar IT budgets and optimizing IT spend.

Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.