Director, Manufacturing Science and Technology (MSAT)

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About Us ... Obsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients. Obsidian's programs apply our cytoDRiVE® technology in Cell and Gene therapy products to control expression of proteins for enhanced therapeutic efficacy and safety. Obsidian's lead program is currently in clinical development for the treatment of patients with metastatic melanoma and non-small cell lung cancer. We're proud of our diverse talented team and committed to cultivating an environment of inclusion where each person feels a strong sense of belonging and is supported to continuously learn and contribute their best work. Our Research team is based in the heart of Cambridge, MA, and Technical Operations team is based in our purpose built facility in Bedford, MA. Obsidianites enjoy a highly collaborative culture, competitive salary and benefits, and potential for ownership through stock options. Our Opportunity... We are looking for a highly motivated Director, MSAT , with a strong background in drug development (preferably autologous cell therapy). You'll serve as the go-to technical leader for manufacturing operations, solving complex problems and translating data into actionable improvements, helping to drive the development of our first clinical stage autologous cell therapy program targeting solid tumors. You will lead end-to-end MSAT strategy and execution, ensuring seamless progression from early-stage development through PPQ and lifecycle management. As the primary technical anchor between Process Development, Quality, and our external partners, you'll ensure the manufacturing processes remain robust, compliant, and efficient; drive deviation investigations to root cause, monitor critical process parameters (CPPs) and critical quality attributes (CQAs), and perform data trending and statistical analysis. You'll be a vital part of a highly collaborative team working to achieve Obsidian's vision by translating innovative science into medical breakthroughs for patients starting with our lead program OBX-115, a novel engineered tumor-infiltrating lymphocyte (TIL) therapy. This is a unique opportunity to be a contributor in a well-funded clinical company with blue chip investors, field-leading advisors, best-in-class partners, and an experienced team. You'll help us build a dynamic, innovative, passionate, collaborative, and successful organization focused on delivering transformative therapies in areas of greatest clinical need. This is a Hybrid role based out of our Bedford, MA location. You Will... Core responsibilities Serve as the lead MSAT interface to CDMOs, providing technical oversight of clinical manufacturing to ensure consistent production, rapid troubleshooting, and accelerated release of engineered TIL therapy batches for patients in ongoing trials. Manage escalations through joint governance forums and collaborate with Process Development and External Manufacturing to align on technical decisions and execution. Define and maintain CPPs, CQAs with CDMOs Partner with Process Development and Analytical Development to define process characterization plans, comparability strategy, and lifecycle control approaches. Define and implement a comprehensive control strategy ahead of PPQ to enable consistent process performance, assure product quality, and support a successful validation and regulatory outcome Own and maintain the integrity of process monitoring databases (CPV, PPQ, and lot history), utilizing statistical tools to monitor process variability, analyze trends, detect shifts, quantify variation, identify signals requiring investigation, and drive data-based insights and decisions. Lead manufacturing campaign review processes. Own PPQ strategy and execution. Oversee authoring and review of batch records, validation protocols, and validation/verification reports. Ensure documentation is scientifically rigorous, operationally usable, phase-appropriate, and compliant. Drive governance of tech transfer plans, protocols, and reports; and process validation documentation. Structure the MSAT team's technical materials for BLA readiness, ensuring lifecycle validation documentation is pristine. Author and/or review relevant CMC sections of regulatory submissions, including the compil ation and lock of all scientifically rigorous MSAT reports and relevant data packages. E nsur e the technical dossier is fully complete and ready for BLA submission . Serve as MSAT subject matter expert in support of FDA interactions, inspection readiness, and PAI execution. Serve as the technical lead in complex or consequential process-related manufacturing investigations/deviations, change controls, complaints, and CAPAs. Partner with External Manufacturing and Quality to ensure consistent investigation standards and timely, effective remediation across CDMO and internal teams. Provide technical leadership for risk management, including facilitating and d

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