Sr. Director, IT Cell Therapy Manufacturing

Job Details:

Job Title: Sr. Director, IT Cell Therapy Manufacturing Site

Location: Devens, MA 01434

Duration: Direct Hire Position

Job Description:

Position Summary

The Sr. Director, Cell Therapy Devens Manufacturing Site IT Lead position plays a critical role in managing all corporate & locally supported infrastructure and software at the Devens, MA Cell Therapy manufacturing site. We are seeking a highly skilled and experienced IT Platform and Product Manager to oversee the IT operations at our manufacturing site. The ideal candidate will be responsible for designing, managing IT platforms, ensuring seamless integration and functionality, and driving product development initiatives. This role requires a strong understanding of manufacturing processes, IT infrastructure, and the ability to collaborate with cross-functional teams to deliver innovative solutions. The role must excel at supporting the site’s daily operations while also developing a strategic IT roadmap for the site. This role will work closely with executive leadership and other key stakeholders to support the organization's growth and success.

This role will report to the Executive Director, Digital/IT - Cell Therapy Manufacturing Operations and will also be part of CTGM IT Leadership Team.

DUTIES AND RESPONSIBILITIES:

• Lead a matrixed organization composed of both site direct reports and groups of indirect reports to deliver effective, innovative and stable solutions that meet the needs of the site. Lead, mentor, and develop a high-performing IT team, fostering a culture of innovation, collaboration, and continuous improvement.
• Active member of the Cell Therapy Site Leadership Team (SLT). Collaborate with site leadership to develop, support, and align strategies for business process improvements through information systems automation.
• Function as the liaison and the single point of contact between site leadership and corporate IT.
• IT Platform Management:
• Oversee the development, implementation, and maintenance of IT platforms to support manufacturing operations.
• Ensure the integration and compatibility of various IT systems and platforms.
• Monitor and optimize platform performance, reliability, and security.
• Product Management:
• Lead the product development lifecycle, from concept to launch, for IT solutions supporting manufacturing operations.
• Collaborate with stakeholders to define product requirements, prioritize features, and create product roadmaps.
• Conduct market research and competitive analysis to identify opportunities for innovation and improvement.
• Project Management:
• Plan, execute, and manage IT projects, ensuring they are delivered on time, within scope, and within budget.
• Identify and mitigate project risks and resolve issues as they arise.
• Track project progress and report on key performance indicators (KPIs).
• Develop and implement comprehensive IT strategies that support the organization's business objectives and growth plans. Ensure the IT applications can support the current and the expected future patient capacity.
• Oversee the development and management of the IT budget, ensuring alignment with financial goals.
• Accountable for continuous operation, maintenance and improvement of process automation systems, MES, LIMS, application integrations, local manufacturing, quality control and quality management site IT systems as well as associated site infrastructure.
• Lead Cell Therapy site service level management scope and process with IT groups and/or vendor managed services, i.e. Service Level Agreements (SLA’s), Disaster Recovery/Service Continuity, etc.
• Provide IT leadership to site regulatory inspection readiness and data integrity initiatives.
• Participate in high-level strategic communications with the business and site leadership teams.
• Ensure the reliability, security, and scalability of the organization's IT infrastructure, including networks, servers, and storage systems. Oversee the implementation and maintenance of disaster recovery and business continuity plans.
• Manage new demand from the various site functions (Manufacturing Operations, Quality, Supply Chain, Manufacturing Science & Technology) through the IT stage gate process.
• Identify key technology trends and how new technologies might be leveraged to provide better solutions to the manufacturing site.
• Negotiate and manage contracts with IT vendors, service providers, and consultants.

Qualifications & Experience

• Bachelor's degree in an Information Technology, life sciences or engineering discipline (Master’s Degree preferred) or a minimum of 12 years of equivalent biotechnology or pharmaceutical industry experience.
• Proven experience in IT platform management, product management, and manufacturing site IT operations.
• Extensive experience in a senior IT leadership role, with a proven track record of successful IT strategy development and execution preferably within a pharmaceutical technical operations environment. Experience should range from manufacturing and quality control systems to GxP quality management systems.
• Demonstrated Strong leadership and team management skills, with the ability to inspire and motivate a diverse team.
• Excellent project management skills, with the ability to manage multiple projects simultaneously.
• Strong analytical and problem-solving skills.
• In-depth knowledge of IT infrastructure systems, change management, staff mentoring, performance evaluation, life-long learning, and diagnosis of sources of problems in both technology and business processes.
• Deep knowledge of regulatory requirements in the areas of current Good Manufacturing Process (cGMP).
• Understanding of regulatory requirements and the role technology plays in satisfying those requirements is essential to this position.
• Thorough understanding of best practices in SDLC and ITIL.
• Effective communication and interpersonal skills, with the ability to influence and engage stakeholders at all levels. Must be client service-driven with excellent relationship management and analytical skills.
• MES, Automation, IT Quality & Compliance, Enterprise System Integrations, IT infrastructure and IT Lab Systems experience preferred.