Position Summary

We are seeking a strategic and experienced Director of Business Systems to lead the design, implementation, and optimization of business systems and technology solutions supporting cell therapy operations. The Director of Business Systems will play a critical role in driving digital transformation initiatives, leveraging technology to enhance operational efficiency, visibility, and agility across the cell therapy manufacturing and supply chain functions.

This position could be located in Gaithersburg, MD, New York City, NY, Waltham, MA, South San Francisco, CA, or Santa Monica, CA

Essential Functions and Responsibilities

• Develop and execute a comprehensive system strategy and roadmap for cell therapy operations, aligning technology investments with business objectives and priorities.
• Lead the implementation of enterprise systems, which could include supply chain management, cell therapy cell orchestration systems, manufacturing execution systems (MES), laboratory information management systems (LIMS), and other business systems, ensuring successful deployment, validation, integration, and adoption across the organization.
• Partner with cross-functional teams to streamline and optimize cell therapy manufacturing and supply chain processes, leveraging technology solutions to drive efficiency, standardization, and automation.
• Establish data management best practices and incorporate into governance frameworks to ensure the integrity, accuracy, and security of operational data, enable actionable insights and analytics-driven decision-making.
• Collaborate with internal and external stakeholders to design and implement integrations between business systems, laboratory instruments, and manufacturing equipment, ensuring seamless data flow and interoperability.
• Lead change management efforts to drive adoption and utilization of new business systems and technology solutions, providing training, support, and communication to stakeholders at all levels of the organization.
• Manage relationships with technology vendors and service providers, overseeing contracts, service level agreements (SLAs), and performance to ensure alignment with business requirements and objectives.
• Drive continuous improvement initiatives to enhance system performance, user experience, and business value, soliciting feedback from stakeholders and implementing enhancements as needed.
• Ensure compliance with regulatory requirements and industry standards related to data integrity, quality management systems, and good manufacturing practices (GMP), implementing controls and safeguards as necessary.

Supervisory Skills

• Support leadership and change management of a growing supply chain organization. Other responsibilities as needed.

Required Skills/Abilities

• Proven track record of successfully leading enterprise-wide system implementations, including cell orchestration, supply chain, ERP, MES, LIMS, and other operational technologies, from requirements gathering to post-implementation support.
• Understanding of cell therapy manufacturing processes, principles, and regulatory requirements, with the ability to translate business requirements into technology solutions that drive operational excellence.
• Project management skills, with experience leading cross-functional teams and managing complex projects in a regulated environment.
• communication, collaboration, and stakeholder management skills, with the ability to build relationships and influence stakeholders at all levels of the organization.
• Demonstrated leadership abilities, with experience leading and developing high-performing teams in a fast-paced and dynamic environment.
• Proficiency in business systems and technology platforms relevant to life sciences manufacturing operations, such as ERP systems (e.g., SAP, Oracle), MES, LIMS, cell orchestration, warehouse, inventory, and data analytics tools.
• Develop solutions to a wide range of complex problems which require a high degree of ingenuity, creativity, and innovativeness. Challenges are unique and solutions may serve as precedent for future decisions.
• Works under consultative direction toward long-range goals and objectives. Assignments are self-initiated with almost no direct supervision.
• Serves as consultant and external spokesperson for the organization on significant matters relating to policies, programs, capabilities, and long- range goals and objectives.
• Provides guidance to team members based on organizational goals and company policy. Work is reviewed in terms of meeting the organization's objectives and schedules.
• Establishes operating policies and procedures that affect subordinate organizational units. Interprets, executes, and recommends modifications to organizational policies.

Education and Experience:

• A minimum of twelve (12) years with BS/BA, or minimum of ten (10) years with MS/MA or MBA, or a minimum of eight (8) years with PhD.
• Bachelor's degree in Information Technology, Computer Science, Engineering, Life Sciences, or a related field; advanced degree preferred.
• Minimum of eight (8) years of experience in business systems analysis, implementation, and optimization, with specific experience in life sciences manufacturing operations highly desirable.