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.
The Senior Scientist will be responsible for performing and managing analytical method development, validation, release and additional assays needed to support cell and gene therapy client programs for The Discovery Labs. The candidate will assist in advancing strategic and scientific direction for the department to establish analytical development, analytical method lifecycle management strategies, and implement novel technologies. The candidate should have experience in team leadership as well as knowledge and skills in analytical development.
- Conduct technical and laboratory activities focused on method development, qualification and analytical strategy for multiple cell and gene therapy programs
- Advance scientific understanding of cell therapy products by applying state-of-the-art cellular analytics research techniques and leading studies that aim to deepen product understanding
- Provide scientific and technical guidance and serve as SME for flow cytometry, molecular, virology and / or cellular analytical capabilities
- Support product development teams to ensure robust data analysis, solid GMP method implementation, and broad incorporation of analytical strategy within Analytical Development and GMP Testing Operations
- Support the design, development, and qualification of analytical methods to assess product identity, purity, quality and potency
- Assist in various aspects of method development, transfer, characterization, investigation and assay validation while collaborating with Cell Therapy Technology, Testing, Process Development, Clinical and Commercial Manufacturing, and Quality teams
- Provide scientific guidance to development operations, and clinical and commercial QC teams. Maintain current awareness of GMP/GTP and other regulations, guidance documents, advisory committees, industry standards and trends that are applicable to current and future Cell and Gene Therapy Development operations and product
- BS biology, Immunology, molecular Biology, or related discipline with 8+ years R&D/analytical development experience or MS with 5+ years analytical development experience
- Previous industry or academic experience in cell and gene therapy, CAR-T research and development is preferred
- Established track record of success supporting early and late stage CMC and clinical product development teams. Cell therapy product characterization, method bridging, comparability, control strategy experience is a plus
- Technical experience in flow cytometry, molecular biology, virology and/or cell-based potency methodologies
- Solid understanding of the fundamentals of ICH and other industry guidelines supporting method development, qualification, and transfer, with a proven ability to assimilate data and growing product knowledge into the broader aspects of CMC development and lifecycle management
- Strategic thinker with excellent problem solving skills