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 Scientist/Engineer is responsible for assisting in the development and implementation of manufacturing processes used to manufacture client cell and gene therapy products at the Center for Breakthrough Medicines. This individual will work with internal and external organizations to plan, execute, and document studies/assessments to support GMP operations stand-up and maintenance, yield process improvements, reduce errors, and support investigations. The Scientist/Engineer will provide ownership and management for process and characterization knowledge related to the GMP production of advanced therapy products.
Additionally, this individual will be responsible for supporting the collection and interpretation of continued process verification data and collaboration with other departments on manufacturing related issues to drive resolution and process improvements. This position will involve hands-on troubleshooting of the manufacturing processes and writing of technical reports.
Other responsibilities include providing assistance in manufacturing led investigations through partnerships with Quality and other business units at the site. Work to determine root cause, implement a solution and a verification check to ensure the fix was effective.
The Scientist/Engineer will be responsible for owning a portion of the process, planning ahead to avoid delays, good documentation practices, and participating in continuous improvement and operational excellence projects to help drive efficiency, while error proofing the process.
TBD