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.
- 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