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Beam is seeking a highly talented and motivated Senior Directory, Commercial Product and Vein-to-Vein Systems Operations leader to join our growing Commercial Patient Operations team. The Senior Directory, Commercial Product and Vein-to-Vein Systems Operations will be responsible for 1) Driving the end-to-end chain-of-identity and chain-of-custody (COI/COC) traceability process; including electronic portal system build in partnership with VP, Patient Operations and IT. 2) Defining and Owning a commercial exceptions management framework, including investigation, escalation, root-cause analysis, and preventive action for patient-specific product events. 3) Treatment center qualification oversight and maintenance, in partnership with Quality and Gene Therapy Operations Teams. This role will be responsible for designing and executing end-to-end validation and writing to support FDA submission. In partnership with Quality and Gene Therapy Operations, this role will define the process, SOPs and training needed to onboard, activate and maintain treatment center qualification to bring a transformative and differentiated therapy to Patients. This role is focused on ristoglogene autogetemcel (risto-cel), formerly known as BEAM-101, an investigational genetically modified ex vivo base editing cell therapy, in patients with sickle cell disease (SCD) with severe vaso-occlusive crises (VOCs).
Job Responsibility:
Establish and lead cross‑functional governance for commercial product execution, including clear ownership, escalation pathways, and decision rights
Drive readiness for regulatory inspections and audits related to commercial product operations and patient‑specific execution
Partner with Commercial, Patient Operations, Gene Therapy Operations, Quality, Supply Chain, and IT to ensure aligned and disciplined execution from order to infusion
Define and execute the COI/COC validation strategy, including SOPs, workflows, risk assessments, and control points across the full patient journey
Translate FDA, FACT, AABB, and other regulatory requirements into practical, auditable, end‑to‑end workflows
Own COI‑related deviation investigations with commercial impact, partnering with Quality and Operations to resolve issues and prevent recurrence
Design and lead a commercial exceptions management framework covering incoming apheresis material, manufactured drug product, logistics, scheduling, and site readiness issues
Lead investigations, root‑cause analyses, escalation management, and CAPA development across Commercial Product Operations in partnership with Manufacturing, Supply Chain, Quality, and Patient Operations
Provide clear, timely communication of execution risks, trends, and mitigation plans to senior leadership
Serve as the business and product owner for Beam’s workflow and traceability portal, partnering with IT on design, build, validation, and ongoing enhancements
Define system requirements, user roles, data standards, reporting needs, and compliance controls
Drive disciplined adoption of portal workflows across internal teams, treatment centers, and external partners
Partner with Quality to lead Treatment Center Qualification and maintenance, including contracting, evaluation, gap analysis, and compliance with FACT, AABB, and FDA standards
Define and execute end‑to‑end processes, SOPs, and training for treatment center onboarding, activation, and ongoing qualification
Ensure centers are operationally ready to execute COI‑compliant apheresis, product receipt, and infusion in a patient‑specific commercial environment
Collaborate with Patient Operations and cross‑functional partners to define and track metrics for COI/COC performance, exception trends, and portal compliance
Build a metrics program to support data‑driven optimization of commercial product and system operations for risto‑cel
Use insights to drive continuous improvement ahead of and through commercial launch
Requirements:
Bachelor's degree or the combination of education and business experience required
Minimum 10+ years of Quality Management, System Management or Commercial Product Operations in Cell and Gene Therapy
Experience supporting FDA BLA submission, inspection and commercial launch required
Experience building or maintaining traceability portal for cell or gene therapy required
Experience with Treatment Center Qualification and Activation for cell and gene therapy required
Strong direct cell or gene therapy commercial experience within the last 5 years
Ability to work independently with very limited supervision
Ability to navigate and be successful in a fast-paced, highly matrixed work environment
Detail-oriented, able to assess and assimilate data and communicate objectively
Good knowledge of GCPs, GMPs, AABB, FACT/JACIE, FDA, EMEA, MHRA, regulations
Effective teaching, training, planning, and problem-solving abilities
Willingness to travel domestically (20% of time)
Strong team player that has patient focused approach and is solution oriented
Excellent listening, communication, and interpersonal skills foster team spirit
A passion for addressing the critical unmet medical needs of patients