The Center for Breakthrough Medicines is on track to be the largest single-site cell and gene therapy contract development and manufacturing organization in the world. Our comprehensive service offering accelerates speed to market through supply chain disruption mitigation strategies, end-to-end program management expertise and unique platform technology with the ability to follow a molecule from idea to commercialization. CBM’s integrated approach provides high quality and consistent end-to-end manufacturing capability including: Process and Analytical Development; Plasmid DNA production; Viral Vector Production of Lentivirus; AAV and Adenovirus; Testing and Analytics; Autologous, Allogeneic and Gene-edited Cell Therapy Bioprocessing; and Cell banking. CBM’s horizontal and vertical integration provides one source throughout a product’s life cycle.
CBM’s mission is to accelerate the delivery and affordability of lifesaving and life-changing therapies from discovery to market by offering a complete solution for the development and commercialization of cell and gene therapies.
CBM is located just outside of Philadelphia in the Heart of Cellicon Valley on The Discovery Labs campus set on 300 acres with 2.4 million square feet of life sciences lab and manufacturing space, allowing clients to scale their development and manufacturing needs without ever having to change sites, while providing employees a true community campus experience focused exclusively on life sciences.
The Discovery Labs is a Global Platform Company inclusive of CBM, The Discovery Labs Properties, UniteIQ incubator labs, and The Colony, a unique investment and resource model enabling groundbreaking therapies to be brought to life.
Summary: The Senior Director of Cell Therapy Manufacturing will be responsible for the overall operational management of the Good Manufacturing Practices and Cell Therapy Manufacturing Facility (GMP), including supervising Study Directors, Project Management, Account Management, specific to analytical testing (e.g., gene therapy, cell-based therapies, tissue engineering, and monoclonal antibodies). They will oversee all day-to-day GMP operations, including project and timeline management, budget, personnel, P&L, facility management, and Quality Control. They will be responsible for ensuring the Cell Therapy Manufacturing delivers all services in a timely, compliant manner, while staying within budget. Key Responsibilities: Directs the day-to-day operations of the Cell Therapy facility and all associated activities through both hands-on activities and supervision of staff. Works with the production line Scientific Directors to develop and enact strategic direction including the determination of project priorities and timelines. Oversees all Cell Therapy Manufacturing resources, including production, facilities, and Quality Control, to meet production goals in alignment with the objectives of the Scientific Directors and the strategic plan. Is responsible for sound project and financial management including preparation of and adherence to budgets and standards for cost measurement. Develops and implements policies and procedures that ensure production activities are compliant with all governing regulatory, environmental, and safety directives.
Education and Experience: Proven ability in analytical/process development to improve and refine analytical testing and scalable production processes for testing in a Cell Therapy Manufacturing environment. Advanced degree in biological sciences Substantial experience in the direction and supervision of staff in a biotherapeutic/cell therapy laboratory environment. Experience in budget management and business development. Willingness to take ownership of all projects