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This position is for a Scientist II in Bioprocess Development at an innovative biopharmaceutical company focused on advancing cell and gene therapy programs. The successful candidate will join a cross-functional team as an individual contributor, playing a crucial role in facilitating Investigational New Drug (IND) applications and Phase I & II enabling activities that are essential for progressing programs towards Biologics License Application (BLA). The role requires a strong background in upstream bioprocessing, particularly in the context of cell and gene therapy, and involves a variety of responsibilities that include designing and executing experiments, optimizing bioprocesses, and collaborating with both internal and external partners to ensure timely delivery of clinical materials. The Scientist II will independently design, develop, and execute experiments aimed at bioprocess development, optimization, and characterization. This includes executing small-scale bioreactor-based cell culture processes for the manufacturing of gene therapy vectors across multiple programs. The role also involves coordinating with various stakeholders to manage deliverables and timelines related to testing and advancing new cell therapy programs from early development through clinical trials. The candidate will serve as the Subject Matter Expert (SME) for all bioprocessing activities that support clinical development and IND/BLA filing, providing technical oversight and guidance, troubleshooting issues, and proposing innovative experimental strategies to ensure that clinical materials are delivered on schedule. Additionally, the Scientist II will be responsible for writing and evaluating Chemistry, Manufacturing, and Controls (CMC) sections and technical reports required for regulatory submissions. This position is critical for the successful advancement of the company’s therapeutic programs and requires a blend of scientific expertise, analytical skills, and project management capabilities.
