Senior Manager, Benchtop IT Systems - Devens Cell Therapy Facility

Role Summary

The Senior Manager, Benchtop IT Systems at the Devens Cell Therapy Facility is responsible for leading the design, deployment, operation, and lifecycle support of laboratory and benchtop IT systems supporting advanced cell therapy manufacturing. This position plays a pivotal role in integrating digital technologies into GxP laboratory environments, ensuring robust compliance, reliability, and alignment with business objectives. The Senior Manager collaborates cross-functionally with laboratory, manufacturing, quality, automation, and global IT teams to deliver solutions that enable scientific innovation and operational efficiency.

Responsibilities

• Lead and manage the end-to-end lifecycle of benchtop and laboratory IT systems (LIMS, CDS, SDMS, ELN, bespoke instrument software) within the Cell Therapy Facility, including requirements gathering, design, implementation, validation, and ongoing support.
• Oversee system integration with manufacturing, quality, and enterprise platforms, ensuring seamless data flow and strong information security.
• Ensure strict adherence to GxP, FDA, and other applicable regulatory standards in system implementation, validation, and operations.
• Partner with internal stakeholders (lab users, engineers, QA, manufacturing) to clarify user needs, recommend scalable solutions, and drive digital innovation at the bench level.
• Direct vendor relationships and manage contractors supporting laboratory IT systems, including service level agreements and performance monitoring.
• Monitor system performance and proactively resolve incidents, collaborating closely with global support teams.
• Develop and maintain robust documentation, validation plans, SOPs, and change control records for laboratory IT systems.
• Drive continuous improvement initiatives, including system upgrades, user training, cybersecurity enhancements, and lifecycle planning.
• Effectively manage operational budgets, resources, and schedules, tracking and reporting progress to site leadership and global IT function.
• Provide leadership, coaching, and mentorship to direct reports and cross-functional project teams.

Qualifications

• Required: Bachelor's Degree (or higher) in Computer Science, Engineering, Life Sciences, or related field.
• Required: 7+ years of experience managing laboratory IT systems in a GMP or GxP-regulated pharmaceutical manufacturing or research environment.
• Required: Deep knowledge of laboratory informatics systems (e.g., LIMS, CDS, SDMS, ELN) and corresponding validation requirements.
• Required: Demonstrated experience leading complex IT or digital projects, preferably in biologics or cell therapy manufacturing.
• Required: Strong understanding of CSV (computer system validation), data integrity, and regulatory requirements in laboratory environments.
• Required: Proven leadership, people management, and cross-functional project management skills.
• Required: Excellent communication, organizational, and stakeholder management abilities.

Preferred Qualifications

• Advanced Degree (MS, PhD, or MBA) in a relevant discipline.
• Experience delivering IT solutions for advanced therapy manufacturing/laboratories (cell, gene therapy, biologics).
• Knowledge of data analytics, cloud platforms, cybersecurity, and modern automation tools as applied to laboratory settings.
• Experience with global organizations and matrix reporting structures.