Director, Business Systems

Arcellx, Inc. (http://www.arcellx.com/) is a clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. Arcellx believes that cell therapies are one of the forward pillars of medicine and our mission is to advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible. Our offices are located in Gaithersburg, Maryland, and Redwood City, California.

Arcellx's lead product candidate, CART-ddBCMA, is being developed for the treatment of relapsed or refractory multiple myeloma (r/r MM) in an ongoing study. CART-ddBCMA has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy designations by the U.S. Food and Drug Administration.

Arcellx is also advancing its dosable and controllable CAR-T therapy, ARC-SparX, through two programs: ACLX-001 for r/r MM and ACLX-002 in relapsed or refractory acute myeloid leukemia and high-risk myelodysplastic syndrome.

The Director, Business Systems will be accountable for developing, leading, and implementing business system solutions to support operational capabilities.  This is a critical role within the organization and will report to the Head of Supply Chain.  It is a highly cross functional position working closely with the senior leadership team from various business groups dealing with GxP systems.

The successful candidate will oversee long-term planning for the function, including the three-to-five-year strategic roadmap and implementation of key system solutions. They will also provide business process development, solution development, project oversight and accountability, and lead all tech ops business systems such as ERP, COC/COI, WMS and MES.

At Arcellx, we value passion, curiosity, determination, and diversity, and look for candidates who demonstrate a genuine interest in our mission and alignment with our values.     

Key Responsibilities: 

• Develop, lead, execute and implement business system solutions to support operational capabilities. This includes the development and roll-out of the Arcellx ERP, CRM and COC/COI systems.
• Oversee the long-term planning, including 3-5 year strategic roadmap and implementation of key system solutions.
• Work closely with the business operations leadership team, sponsors, and other key stakeholders to understand their technology requirements and identify/implement “best fit” technology solutions to meet their needs.
• Operational ownership of various systems in an FDA regulated biotech or pharmaceutical environment.
• Bring best practices to deliver solutions for the business problems through experience driven vision, planning, and hands on experience within a regulated GxP environment.
• Accountable for the prioritization and execution of new systems and/or enhancements to existing systems.
• Responsible for the prioritization and execution of new systems and/or enhancements to existing systems.
• Enforce governance and change control amongst business teams to prioritize and implement improvements for all business operations systems.
• Collaborate closely with other groups on the overall solutions delivery process, infrastructure, and database requirements.
• Assist in evaluating vendor solutions, develop alternatives, and recommend technical solutions in meeting the evolving needs for Arcellx.
• Lead and manage system implementations and integrations from requirement management through testing and validation.
• Collaborate with stakeholders on computerized system validation (CSV) activities like IQ/OQ/PQ and other regulatory requirements to ensure the compliant and validated state of all quality systems.
• Responsible for the tools, automated testing, and resources to support CSV activities.
• Accountable for system administration and integration.
• Assist in developing, modifying, and reviewing SOPs, work instructions, and other relevant documentation for quality systems administration.
• Manage internal and external teams to implement, deploy, and manage GxP systems.
• Identify and lead the implementation of analytics solutions for stakeholders to deliver KPIs related to data and process monitoring.

Qualifications: 

• 12+ years’ experience working within a GxP regulated setting (laboratory, quality, manufacturing, IT).
• Knowledge of cGMP/ICH/FDA regulations with 21 CFR Part11; GAMP knowledge.
• 10+ years of experience in implementing and integrating systems with other enterprise and technical operations systems.
• Experience in implementing, integrating and supporting systems including ERP (SAP/Oracle), learning management systems (LMS), and customer relationship management (CRM) systems.
• Experience with manufacturing execution system, electronic batch records systems, and integration with LIMS will be a plus.
• Experience in defining the requirements for data warehouse with data from various quality, product development, and manufacturing systems.
• Experience in handling infrastructure and instruments qualifications and validations for regulatory requirements.
• Experience with emerging cloud, SaaS, and web technologies.
• Ability to handle conflicting priorities from various business groups and prioritize them based on the business requirements and resource availability.
• Experience in implementing and leading change management and governance process, owning deviations and change control in a regulated environment.
• Effective organization and time management skills, with the ability to work under pressure and adhere to project deadlines in a fast-paced environment.
• Excellent presentation and written and verbal communication
• Strong executive presence with the ability to influence and interact with senior leadership team from various business groups.
• Proficient in tools like PowerPoint, Visio, and other tools to develop process flows and presentations.
• Experience in leading, managing, and mentoring a team.

Competencies:

• Has character and integrity. Committed to always doing what’s right.
• Self-motivated and able to work autonomously. Can produce top-quality work with little oversight.
• "No job is too small" mentality. Humble and willing to help others.
• Able to build strong relationships and collaborate effectively with colleagues.
• Gives direct, candid, and respectful feedback. Can receive feedback with curiosity and without getting defensive.
• Always looking to improve and challenge the status quo. Gritty and determined.