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Obsidian Therapeutics is seeking a Senior Manager for External Manufacturing to lead oversight of viral vector and ancillary material production for engineered cell and gene therapies. The company is developing transformative cell therapy programs, including amsoki-cel (OBX-115), a tumor-infiltrating lymphocyte (TIL) therapy for metastatic melanoma and non-small cell lung cancer, leveraging their proprietary cytoDRiVE® platform.
In this role, you will manage the manufacturing value stream across a network of CDMO partners, ensuring supply chain continuity, high-quality production, and on-time delivery to support clinical programs. Key responsibilities include:
• Deep understanding of viral vector, ancillary material, and autologous cell therapy drug product manufacturing processes to drive exceptional success rates and product consistency
• Oversight of CDMO partner execution across the manufacturing network, managing production scheduling, training, and operational performance
• Leadership of critical investigations, technical batch record reviews, MBR/EBR revisions, change controls, and continuous improvement initiatives
• Establishment of a new manufacturing specialist function responsible for deviation management, change control, MBRs, and continuous improvement across the manufacturing network
• Monitoring and reporting on CDMO performance metrics, identifying operational strengths and improvement opportunities
• Ensuring ongoing operational readiness at CDMOs, including operator training, equipment readiness, and materials management
• Management of site performance improvement plans, financial reporting, and budget adherence
You will be part of a highly collaborative Technical Operations team based in Bedford, MA, working alongside research teams in Cambridge. The company offers competitive salary, benefits, and stock option ownership. This is a hybrid role with primary location in Bedford.
