Associate Director, Information Technology

About Us

RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people’s lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science.

We live every day by our core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance.

About the Role

The Associate Director of Information Technology is a leadership position responsible for the software system lifecycle: selection, design and configuration, validation, deployment, upgrade and maintenance, continuous improvement, and decommissioning. The major software system in deployment is the Material Management and Manufacturing Execution System (MES), currently POMS. The role also includes support for systems such as the QMS, label printing, validation, and equipment software. The individual will manage the local IT support team and work closely with site business teams and the Global IT Infrastructure, support, and security team.

Responsibilities

• Leadership and Management:
  • Lead the site ITS team and represent ITS on the site leadership team.
  • Develop and manage the US site IT budget.
  • Ensure the achievement of site digital transformation and global IT goals, including system implementation, infrastructure, desktop support, and cybersecurity.
• Software Development and Management:
  • Manage relationships with GMP technology vendors, solution providers, consultants, and outsourcing firms.
  • Oversee consulting engagements to achieve stakeholder satisfaction and cost efficiency.
  • Handle negotiation and relationship management for GMP technology partners, including initial and annual due diligence, renewals, pricing, technology comparisons, and evaluations.
  • Support integration, validation, administration, and maintenance activities of the site's GMP computer systems.
  • Serve as a site leader in cGMP manufacturing software technology configuration and deployment, develop technical expertise, and conduct on-site training.
  • Stay informed about strategic and emerging technologies and implement new technologies/services where they deliver meaningful value.
• Manufacturing Execution System (MES):
  • Function as a site technical expert for all questions and issues related to the MES system supporting the manufacturing of cell therapy products.
  • Perform and direct the design, configuration, and recipe authoring activities of the site's MES application.
  • Directly support operations with troubleshooting and issue resolution related to the MES system.
  • Lead MES projects to meet deliverables, technical, budget, and schedule goals, including managing internal and external resources.
  • Support the life-cycle maintenance of GMP manufacturing systems, including software backups, updates, diagnostics, documentation, and obsolescence planning.
  • Act as an MES subject matter expert to assist in regulatory audits and investigations.

Requirements

• BS in Computer Science, Engineering, Engineering Technology, or other Technical Degree.
• Minimum of 7 years’ experience working in a regulated GMP environment, preferably in biopharmaceutical manufacturing.
• Evidence of teamwork, leadership, and initiative-taking, including management experience.
• Prior MES experience with Emerson Syncade, Werum PAS-X, or POMS required.
• Understanding of Warehouse and Inventory management, specifically implementation of ERP systems in a GMP facility.
• Demonstrated proficiency with experience designing and implementing EBR recipes using GAMP5, S88, and S95 standards.
• Familiarity with cybersecurity compliance and information security in a compartmentalized scientific/technical R&D and business computing environment.
• Proficient with MS Word, Excel, PowerPoint, and other MS Office suite applications.

Culture and Values

All RoslinCT employees embrace the principles of our culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways.