Associate Director - IT Software Systems

Job Description

Job Description

WHO WE ARE

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.

THE ROSLINCT WAY

Here at RoslinCT, our team can contribute to the development of revolutionary treatments. 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. Our people are the key to our success. At RoslinCT we focus on developing our corporate culture, people’s development, growth, and the ability to impact patients.

ACCELERATING YOUR FUTURE

The Associate Director of IT Software Systems is a leadership position that will plan, direct, and be 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. Responsibility will also include support for systems such as the QMS, label printing, validation and equipment software.

The role will manage the local IT support team. The individual will work in close

collaboration with the site business teams and the Global IT Infrastructure, support and security team.

How You Will Make an Impact:

Leadership and management:

· Lead the site ITS team and represent the ITS on the site leadership team.

· Responsible for developing and managing US site IT budget.

· Ensure the achievement of site digital transformation and global IT goals such as system implementation, infrastructure, desktop support and cyber security.

Software development and management

· Manage relationships with GMP technology vendors, solution providers, consultants, and outsourcing firms. Manage consulting engagements to achieve both stakeholder satisfaction and costs.

· Negotiation and relationship management for GMP technology partners, including initial and annual due diligence, renewals and pricing, technology comparisons, and evaluations.

· Support integration, validation, administration, and maintenance activities of the site's GMP computer systems.

· Be a site leader in cGMP manufacturing software technology configuration and deployment, develop technical expertise, conduct on-site training, etc.

· Stay informed about strategic and emerging technologies. Adopting and implementing new technologies/services where it can deliver meaningful value to RoslinCT.

Manufacturing Execution System

· 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 with respect to the MES system.

· Lead MES projects to meet deliverables, technical, budget, and schedule goals including managing the work of internal and external resources and following up to ensure the desired result has been achieved.

· Support the life-cycle maintenance of GMP manufacturing systems including developing programs for software backups, updates, diagnostics, documentation, and obsolescence planning.

· Capable of being an MES subject matter expert to assist in regulatory audits and investigations.

Qualifications;

· BS in Computer Science, Engineering, Engineering Technology, or other Technical Degree with a 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 and 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.

OUR COMMITMENT

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.

RoslinCT is proud to be an equal-opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.