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.
Cell and Gene Therapies Drug Product Development (CGDPD) is a department within a Process Development Division in Center of Breakthrough Medicines. CGDPD is responsible for formulation, process and device development for various modalities of allogeneic and autologous cell and gene therapies. CGDPD represents a unique diverse team of scientists driving end-to-end Drug Product development efforts in advanced therapies. The Senior Scientist role will be responsible for advancing CBM expertise in cell therapy manufacturing processes and tech transfer for both autologous and allogeneic drug products. He/she will play a critical role in progressing technology transfer, process development and associated manufacturing of clinical and commercial cell therapy drug products.
- Drive innovations through evaluation of novel cell therapy process workflows, identification of new instrumentation and testing of emerging platforms.
- Plan, execute and interpret process development experiments for various modalities of cell therapies such as CAR-Ts, CAR-NKs, TILs, Tregs, iPSC and others.
- Lead process development studies to determine and characterize process parameters associated with preparation of cell therapy drug products, including formulation, filling, cryopreservation, and inspection.
- Design and support container closure selection for autologous and allogeneic cell therapies.
- Contribute to technical discussions aimed at resolution of issues with suppliers, processes, and deviations
- Prepare technical reports and present the finding to colleagues and management
- Interface with clients to establish/maintain a positive relationship, ensure expectations are clear, plan for right-first-time execution, and complete studies to successfully deliver against the program
- Follow general laboratory safety and training requirements
- Experience with large molecules or novel modalities is required.
- Familiarity with clinical preparation and administration procedures
- Experience with authoring regulatory documents for IND/IMPDs
- Experience with formulation development of cell and gene therapies is a plus.
- Understanding and experience with cell therapy cryopreservation is a plus.
- Organizational skills to drive and execute process development studies
- Working knowledge in DOE, data and statistical analysis is preferred
- Ability to work collaboratively but independently
Education & Experience
- Ph.D. in Chemical Engineering, Bioengineering, Biotechnology, or equivalent life sciences field with 1+ years’ experience, MS with 5+ years, BS with 7+ years.