CBM

Full Time EE

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.

Summary

Center for Breakthrough Medicines is seeking a highly motivated and independent researcher to join the viral vector Research & Development Team to establish purification strategies for Adeno-Associated Virus, Lentivirus, and Adenovirus (AAV, LV, and Ad). The scientist will play a key role in creating best-in-class viral vector manufacturing technologies. This position will be primarily responsible for the development of down-stream processes for the purification and analytical characterization of in process material for all viral vectors AAV, LV, Ad and others. The Associate Scientist position in the Viral Vector R&D group at the Discovery Labs offers an exciting opportunity to develop viral purification and analytical strategies for Gene and Cell Therapies to treat many diverse unmet medical needs.

Responsibilities

• Conduct technical and laboratory activities focused on method development, qualification and analytical strategy for multiple cell and gene therapy programs
• Support product development teams to ensure robust data analysis, solid cGMP method implementation, and broad incorporation of analytical strategy within Analytical Development and cGMP 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 cGMP/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

Education & Experience

• BS/MS in biology, virology, molecular Biology, chemical engineering, or related discipline with 2-5 years R&D/analytical development experience.
• Previous industry or academic experience in cell and gene therapy, CAR-T research and development is preferred
• Foundational knowledge of viral purification by AKTA-based affinity/IEX chromatography, ultra-centrifugation, filtration as well as be familiar with analytical QC assays including qPCR/ddPCR, silverstain/western blotting, UNCLE/STUNNER, DLS/DSF, ELISA, and imaging
• Solid understanding of AAV/LV/Ad virus biology is highly preferred.
• Strong communicator capable of delivering data-based reports in all relevant formats
• Strategic thinker with excellent problem-solving skills