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Obsidian Therapeutics is seeking a Senior Manager of External Manufacturing to lead oversight of viral vector and ancillary material production for engineered cell and gene therapies. The role is based in Bedford, MA (hybrid) within the Technical Operations team.
You will manage the external manufacturing value stream for Obsidian's lead program, Amsoki-cel (OBX-115), a novel engineered tumor-infiltrating lymphocyte (TIL) therapy in clinical development for metastatic melanoma and non-small cell lung cancer. Key responsibilities include:
- Deep understanding of viral vector, ancillary material, and autologous cell therapy drug product manufacturing processes to ensure exceptional success rates, product consistency, and on-time delivery
- Oversight of viral vector and ancillary drug substance manufacturing across a network of CDMO partners to ensure supply chain continuity and high-quality clinical supply
- Management and collaboration on critical CDMO investigations, technical batch record reviews, MBR/EBR revisions, change controls, and continuous improvement projects
- Monitoring CDMO performance metrics and driving understanding of operational strengths, strategic initiative outcomes, and improvement opportunities
- Establishment of a new phase-appropriate manufacturing specialist function responsible for deviation management, change control, MBRs, and continuous improvement across the manufacturing network
- Oversight of production scheduling adherence, CDMO training, site performance improvement plans, operational readiness, financial reporting, and budget management
You will be part of a highly collaborative Technical Operations team at a well-funded clinical-stage biotech company with blue-chip investors and best-in-class partners. The role offers the opportunity to contribute to translating innovative science into transformative therapies for patients with serious unmet medical needs.
