Position Description

The Manager, Gene Therapy Operations, is a critical role within the Patient Operations organization and is responsible for end-to-end (enrollment to infusion) oversight and execution of critical gene therapy supply chain operations for Genetix’s three commercially approved therapies.

This role partners closely with Manufacturing, Quality, Commercial Strategy & Operations, Sales, Systems Teams, and Logistics to ensure uninterrupted, world class patient and customer support.

This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.

Job Responsibilities

• Execute and manage the day-to-day supply chain and logistics operations of gene therapy from patient enrollment to infusion of drug product
• Coordinate patient scheduling with internal team, ensure scheduling tasks in associated systems and trackers are updated and communicated in a timely manner. Oversee the external CMO scheduling functions as appropriate
• Manage, maintain, and improve customer relationship with QTCs in partnership with apheresis and commercial teams
• Live monitoring and on call support during apheresis and final drug product logistics movements to ensure delivery is timely and secure
• Own and manage CMO slot utilization
• Execute tasks in accordance with all governing Policies, Standard Operating Procedures, Work Instructions, and Job Aids
• Contribute to a culture of continuous improvement, think proactively to offer solutions to problems

Required Education, Experience, and Qualifications

Required:

• Bachelor’s degree in Life Sciences, Engineering, or related discipline
• 5+ years of experience in pharmaceutical supply chain, planning, scheduling, gene therapy systems, project management, customer service and relationship management within the biotech industry
• Prior experience working in GxP regulated environments

Preferred:

• Experience within Sickle Cell Disease, Beta Thalassemia, and autologous cell and gene therapy supply chain

Key Competencies:

• Excellent attention to detail, must be able to manage and organize own work independently and in coordination with a team
• Ability to navigate systems such as Oracle, Traceability Systems, Veeva efficiently
• Excellent, clear, concise, and empathetic communication
• Able to execute tasks with a sense of urgency and manage time effectively. Must be comfortable operating in a fast-paced, evolving environment
• Ability to adapt to fluctuating relationship dynamics with internal and external partners

Position Description:

The Director, Apheresis Operations, is a leadership role within Patient Operations and is responsible for providing strategic and operational oversight of the apheresis operations team that supports Genetix’s three commercially approved therapies. This role is field based and requires frequent travel to Qualified Treatment Centers (QTC) to engage with our customers and care teams in-person. This role will develop and expand the strategic partnerships and relationships with external partners and evolve the internal team to meet the demands of our growing commercial business. The ideal candidate will enhance and expand on the existing technical and medical knowledge of the organization. The apheresis operations team is a highly skilled and technically knowledgeable group of individuals responsible for: 1) QTC onboarding, training, qualification, 2) data analytics and metric tracking on collections, 3) onsite/remote cell collection support and optimization, and 4) final Drug Product infusion support.

This role partners closely with Manufacturing, Quality, Commercial, Patient Management & Logistics, Medical, and Systems Teams to ensure uninterrupted, world class patient and customer support.

This position is a US Remote position. Domestic travel 50% or more of the time is required for this role.

Job Duties and Responsibilities:

Core Responsibilities:

• Lead, engage, evolve, and elevate the Apheresis Operations team to match evolution of our commercial business
• Extensive technical expertise, with strong focus on medical and apheresis operations experience
• Gather and analyze key data metrics, perform KPI tracking to inform continued improvements to our process and patient journey experience

Field Responsibilities:

• Travel domestically, 50% or more of the time across our national QTC network for engaging internal and external collection teams, cell therapy labs, treating physicians and teams, and patients as required to provide individualized, white glove customer service and establish partnership with teams involved
• Set the standard of relationship management and communications for the apheresis operations team, provide internal team coaching and field training

Other Responsibilities:

• Serve as subject matter expert for internal and external apheresis education
• Partner with Quality, Technical Development & Operations, and Commercial teams to build a robust treatment center network including center selection, qualification, training and ongoing support
• Oversee and drive the strategy and process improvements for QTC qualification, training, ongoing support
• Ensure compliance with regulatory standards and requirements, oversee management of team owned quality system records, (deviations, CAPAs, change controls, proactive initiatives)
• Drive the identification, sharing, and adaptation of best practices cross-functionally and between centers that will improve overall treatment experience of our patients

Essential/Required Qualifications:

Required:

• Bachelor of Science in Nursing (BSN), Registered Nurse (RN), Qualification in Apheresis (QIA) preferred, or minimally, Bachelor’s degree in Life Sciences, Engineering, or related discipline (advanced degree preferred)
• 10+ years of progressive experience in Apheresis Operations, Cell and Gene Therapy, Commercial Operations, Treatment Centers
• Prior people leadership experience at the Associate Director or Director level within the industry
• Demonstrated experience leading a field-based team, and working in the field
• Knowledge of GMP regulations (FDA, EMA, ICH)
• Direct apheresis experience within the last 5 years
• Domestic travel, 50% or more of the time
• Passion for bringing curative therapies to patients

Preferred Qualifications:

• Experience within Sickle Cell Disease, Beta Thalassemia, and autologous cell and gene therapy
• Experience working in BioPharma

Key Competencies:

• Primary focus on driving process improvements which have a demonstrable impact on the business
• Enhance apheresis technical knowledge, utilizing this expertise to educate internal and external groups. Key focus on how to improve collections, show up with executive presence at conferences, drive and oversee apheresis summits to be a leader in the industry
• Excellent communication and partnership with internal and external groups and individuals
• Detail oriented, anchor to and utilize data to drive sound business decisions
• Strategic thinking, with an ability to translate into operational plans
• Ability to adapt to fluctuating relationship dynamics with internal and external partners
• Excellent listening and conflict management skills. Team player, flexible to the needs of a wide range of personalities