External Manufacturing/MSAT Manager
5 days ago
We are seeking an experienced External Manufacturing/MSAT Manager to join our Technical Operations team in Bedford, MA. As a critical member of our team, you will work closely with our CDMO joint project team and Obsidian's Process Development, Analytical Development, Quality Assurance, Quality Control, and Regulatory teams to ensure effective tech transfers and start-up of manufacturing processes according to agreed upon timelines in support of business objectives.
About UsObsidian Therapeutics is expanding the reach of TIL therapy. We are pioneering engineered tumor infiltrating lymphocyte (TIL) therapies to deliver transformative outcomes for patients suffering from solid tumor malignancies. Our research team is based in Cambridge, MA, and our Technical Development, Manufacturing & Quality team is based in Bedford, MA. We're proud of our diverse talented team and committed to cultivating an environment where each person feels a strong sense of belonging and is supported to continuously learn and contribute their best work.
Job Requirements- Bachelor's degree in biological sciences, (bio)chemical engineering, or related discipline with 8+ years of experience (or MS with 6+ years) working in a Manufacturing or MSAT role in the Cell and/or Gene Therapy space.
- Strong understanding of aseptic processing and cGMP requirements and their application to autologous cell culture manufacturing.
- Successful client-side experience overseeing work completed at a CDMO/CMO - including change, deviation, CAPA, and Tech Transfer management.
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Cybersecurity Manager
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Quality Assurance Manager
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Operations Manager
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