Director, Information Technology

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

The IT Site Leader oversees all technical things for the site, which means they need to know IT terminology, networks, infrastructure and how to manage projects effectively. Ensure that projects get done correctly and creatively solve problems when something goes wrong, or new challenges arise. Acts as the subject matter expert and single point of contact with the site operations and business leadership team regarding any topic as it pertains to information technology. The IT site leader is capable of understanding business requirements and priorities of one or multiple assigned sites and translating such into IT requirements.

This role acts as the primary liaison between IT and manufacturing operations, ensuring that IT operations, and digital solutions align with business goals, regulatory requirements, and operational excellence. You will manage the local IT team and drive local digital transformation, support GMP-compliant systems, infrastructure, compliance initiatives and enable data-driven decision-making across the site.

You will be a part of IT leadership team, collaborating in EU, US and Japan, as well as Copenhagen site leadership team working together to support both global and local agenda.

Essential Job Duties/Responsibilities

• Maintain close relationships with business partners to understand, prioritize and provide solutions to the business
• Build and maintain a close working relationship with the internal peers and the larger IT organization to provide services around networks, hosting, process control, monitoring, and IT security
• Internal & External partner management at local and global IT level
• Manage local budgets and provide input to the regional and global budgeting process
• Ensure Site-IT Infrastructure lifecycle management and align to capacity growth proactively with accurate forecasts
• Responsible for managing the local 24x7 escalation process of problems to appropriate support personnel. Evaluate business needs and alignment of work environment for possible process improvements and implementation accordingly
• Identify opportunities for digital innovation and process optimization within manufacturing operations.
• Lead or be accountable for the site implementation of IT projects, including MES, LIMS, ERP, routine IT infrastructure and operations projects.
• Ensure projects are delivered on time, within scope, and in compliance with GxP and data integrity standards.
• Collaborate with global IT teams to align local initiatives with enterprise architecture and cybersecurity policies.
• Facilitate communication between IT and cross-functional teams including Quality, Engineering, Production, and Supply Chain.
• Conduct regular reviews with stakeholders to assess IT service performance and identify improvement areas.
• Ensure all IT systems and processes comply with regulatory requirements (e.g., FDA, EMA, GAMP 5).
• Participate in audits and inspections, providing documentation and technical expertise as needed.
  
  

Leadership Skills

• Experienced in people management
• Excellent teamwork and collaborative skills
  
  

Required

QUALIFICATIONS

• Bachelor’s or Master’s degree in Computer Science, Information Systems, Engineering, or related field.
• 5+ years of experience in IT roles, with at least 2 years in a manufacturing or pharmaceutical environment.
• Strong understanding of GMP, GxP, and regulatory compliance in pharma manufacturing.
• Experience with systems such as MES, SCADA, LIMS, ERP (AX2012/D365), data historians, IT infrastructure, operations .
• Experience in analysis, implementation and evaluation of IT systems and their specifications
• Sound understanding of computer systems (hardware/software), networks etc.
• Experience working with insourced and outsourced IT operations
• Strong analytical and problem-solving skills
• Excellent organizational and leadership skills
• Proven ability to manage projects and influence stakeholders at all levels.
• Excellent communication skills
• Fluent in English; local language proficiency is a plus.
  
  

Preferred

• ITIL or PMP certification.
• Experience with cloud platforms and cybersecurity in regulated environments.
• Ability to create structure in a busy work environment.
  
  

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.  Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.