Director of Cell Therapy Patient Operations

Director,Cell Therapy Patient Operations 

BrainChild Bio is seeking an experienced, collaborative and results-driven leader to establish our Patient Operations capabilities. The key role will manage and orchestrate the end-to-end time sensitive, , patient cell supply chain for our autologous cell therapy products. This leader will work with internal teams, external vendors, and clinical sites to ensure seamless coordination of all activities from order placement through drug product delivery.  

The Director, Cell Therapy Patient Operations,will report to Senior Vice President of Program Management and Product Delivery and work closely with leadership in Manufacturing, Quality, Supply Chain and Clinical to ensure systems are implemented and maintained to support the teams’ responsibilities. You will initially focus on capability building (process, system, people, data) and then transition to day-to-day activities and process improvements. The ideal candidate is an individual that can be both tactical and strategic and is willing to roll up their sleeves to achieve our objectives. If you love to build teams and processes, thrive in a fast-paced environment and are looking for a role where you’re given ownership and accountability, come join us! 

• Establish the new function that integrates responsibilities related to the autologous cell supply chain including Apheresis Operations, Cell Therapy Scheduling and Cell Logistics integrating with Clinical Operations and Technical Operations 
• Create and implement systems and tools required to support Patient Operations processes including but not limited to: 

• Lead Cell Apheresis Operations including supporting new clinical site start-up and qualification and on-going management of cell collection activities 
• Ensure compliance with all relevant regulations and standards (e.g., FDA, cGMP, cGTP, etc.) 
• Delivera high level of customer service and effectively communicate with internal business partners and external customers (e.g., CDMO, CRO, and Clinical Sites) regarding slot allocation, the scheduling and transportation of apheresis collections, manufacturing milestones, product availability and drug product delivery 
• Participate in project and program teams, as required 

• Bachelor’s degree in Logistics, Supply Chain or related field and at least 10 years of experience in the pharmaceutical or biotech industry  
• Minimum 3 years’ experience working in autologous cellular therapy 
• Minimum of 3 years’ experience in a team and/or cross-functional leadership role 
• Experience building teams, 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