Abeona Therapeutics Inc. (ABEO) is a clinical-stage biopharmaceutical company developing cell & gene therapies for serious and life-threatening diseases. We have filed a biologics license application (BLA) for our lead gene therapy asset: prademagene zamikeracel (pz-cel) for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). RDEB is an ultra-rare inherited connective tissue disorder that leads to highly fragile skin, painful wounds and systemic complications resulting in early death. Pz-cel BLA is currently under priority review by the FDA with a target action date of May 25, 2024.

　　We are looking for an experienced, collaborative and results oriented leader to build and lead Abeona’s Cell Therapy Patient Operations. The Patient Operations Team will manage and orchestrate the time critical, end to end, patient cell supply chain for Abeona’s commercial cell therapy and work with internal Abeona teams and external customers to coordinate all relevant activities from order placement through drug product delivery.

　　General Essential Duties and Responsibilities:

　　Establish the new function that integrates responsibilities related to the autologous cell supply chain including Cell Procurement Operations, Cell Therapy Scheduling and Cell Logistics.

　　Lead Cell Procurement Operations including supporting new commercial site start-up and qualification and on-going management of cell collection activities.

　　Lead Cell Therapy Scheduling and Cell Logistics responsible for coordinating and managing patient orders with internal teams, external logistics partners and Commercial treatment sites from autologous cell collection through Final Product delivery.

　　Ensure compliance with all relevant regulations and standards (e.g. FDA, cGMP, cGTP, etc.).

　　Pre-Launch Essential Duties and Responsibilities:

　　Collaborate with Manufacturing, Supply Chain, Quality, Clinical and Commercial to ensure scalable Patient Operations business processes are developed and implemented in support of Abeona’s commercial launch. This includes cross-functional work/data/communication flows, SOPs, forms, work instructions and training materials.

　　Ensure Patient Operations related materials needed to support Commercial Site onboarding are developed.

　　Work with Tech Ops and Commercial Leadership to ensure a slot planning and allocation business process is developed and implemented.

　　Select and contract 3rd party logistics partners to support cell transportation.

　　Create and implement systems and tools required to support Patient Operations processes including but not limited to:

　　Scheduling and slot planning and allocation tools

　　Tracking of scheduling and cell logistics related milestones and event triggers (planned and actuals) from patient enrollment through final product delivery

　　Site notifications and communication of product availability (range and confirmed dates)

　　Management of scheduling related contacts and addresses

　　Management of calls and cases

　　Hire and train additional team members required to support planned commercial sites and patient volumes.

　　Support the Commercial Account Management Team with new site onboarding, training, and coordination of mock shipments and dry runs, as needed.­­

　　Post-Launch Essential Duties and Responsibilities :

　　Manage the end-to-end order process and ensure it is appropriately executed for each commercial patient.

　　Ensure all team members are providing a high level of customer service and effectively communicating with internal business partners and external customers (treatment sites) regarding slot allocation, the scheduling and transportation of biopsy collections, kit distribution, manufacturing milestones, product availability and drug product delivery.

　　Manage continued on-boarding and performance of the cell collection operations according to program plans and procedures.

　　Provide Quality Systems support through management of investigations and impact assessments for any deviations associated with cell collection operations, cell therapy scheduling or cell logistics.

　　Ensure team is reacting to any issues in scheduling and cell logistics with urgency and triaging to the appropriate teams to resolve, including outside of normal business hours.

　　Represent team on selection and implementation of Cell Orchestration System.

　　Serve as a key cross-functional leader in the Technical Operations and Commercial Operations interface, including leading cross-functional meetings and leading the development, measuring and reporting out on key metrics.

　　Continue to build and manage the team in support of the commercial program.

　　Implement continuous improvement program for team.

　　Participate and project and program teams, as required.

　　Qualifications and Education Requirements:

　　Bachelor's degree in Logistics, Supply Chain or related field and at least 8 years of experience in the pharmaceutical or biotech industry, and 3 years' experience working in autologous cellular therapy.

　　Minimum of 3 years’ experience in a team and/or cross-functional leadership role.

　　Experience building organizations, including development of organizational design, hiring of personnel and design and implementation of business processes.

　　Strong understanding of and experience with GMP and GTP requirements.

　　Experience with the design, implementation, and use of cell therapy orchestration systems

　　Must display strong analytical and problem-solving skills.

　　Demonstrated ability to work cross-functionally, develop and maintain strong internal and external partnerships and influence other functions within the organization.

　　Self-motivated, flexible and creative, able to prioritize and work in a fast-paced and demanding start- up environment.

　　Powered by JazzHR