Note: The job is a remote job and is open to candidates in USA. Beam Therapeutics is a biotechnology company committed to establishing a leading platform for precision genetic medicines. They are seeking a highly motivated Associate Director/Director of Gene Therapy Operations to oversee treatment center onboarding, patient coordination, and drug product delivery activities, ensuring a high-quality experience for patients and providers.
Responsibilities
- Lead operational on-site onboarding, training, and qualification of apheresis and treatment centers
- Conduct operational readiness assessments (apheresis, cell therapy lab, pharmacy, infusion workflows)
- Support treatment center activation and certification, ensuring readiness for commercial operations
- Provide ongoing post-activation support and retraining as needed
- Partner with Patient Operations and treatment centers to coordinate patient scheduling across apheresis, manufacturing, and infusion
- Act as the field escalation point for scheduling challenges, delays, and exceptions
- Ensure alignment across treatment center, manufacturing, and internal teams to maintain timeline adherence
- Provide hands-on apheresis expertise and guidance to treatment centers
- Support cell collection optimization, including yield, quality, and procedural consistency
- Troubleshoot collection challenges and partner cross-functionally to resolve issues in real time
- Support treatment centers with drug product receipt, storage, thawing, and administration readiness
- Ensure adherence to handling protocols and quality standards
- Provide guidance during infusion preparation and day-of-treatment activities, as needed
- Ensure strict adherence to Chain of Identity (COI) and Chain of Custody (COC) processes throughout the patient journey
- Reinforce compliance with FACT, AABB, and regulatory requirements
- Identify, document, and support resolution of deviations and operational issues
- Serve as the primary operational point of contact for treatment center stakeholders (apheresis, CTL, nursing, pharmacy)
- Build trusted relationships to drive high-quality execution and customer experience
- Partner cross-functionally with KAMs, MSLs, Patient Operations, Quality, and Technical Operations
- Capture and communicate field insights, best practices, and trends
- Contribute to process optimization and standardization initiatives
- Support data collection and reporting to inform collection efficiency, scheduling performance, and patient outcomes
Skills
- Bachelor's degree required
- 8+ years of healthcare experience, including experience in cell & gene therapy or apheresis operations
- Direct hands-on apheresis experience required
- Strong understanding of apheresis and cell collection processes
- Strong understanding of cell therapy workflows (COI/COC, product handling, infusion)
- Strong understanding of regulatory standards (FACT, AABB, GxP)
- Ability to operate independently in a field-based, highly matrixed environment
- Strong problem-solving and escalation management skills
- Excellent training, teaching, and clinical communication abilities
- High attention to detail with a strong focus on quality and compliance
- Patient-centric and customer-focused mindset
- Willingness to travel >60% (field-based role)
- Ability to support on-site activities at treatment centers, including apheresis and infusion days
- Advanced degree (RN, BSN, MPH, MBA)
- Experience supporting treatment center onboarding and/or commercial CGT operations strongly preferred
- Experience with autologous CGT products and SCD preferred
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