Senior Manager​/Associate Director, External Manufacturing

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.

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.

We are looking for a highly motivated Senior Manager/Associate Director External Manufacturing, with a strong background in CDMO management of viral vector and ancillary materials production. As a key contributor within the External Manufacturing organization, you’ll lead front-line oversight of viral vector and ancillary material production, helping to drive the development of our first autologous cell therapy program targeting solid tumors In addition, you’ll establish a new phase appropriate manufacturing specialist function that will be responsible for deviation management, change control, MBRs, and continuous improvement across the manufacturing network.

You’ll be responsible for the manufacturing value stream, including adherence to production scheduling, CDMO training, site PIP management, CDMO operational performance, triage and management of investigations, batch record revisions, change controls, continuous improvement, CDMO operational readiness, financial reporting and budget adherence.

As a member of our Technical Operations team, you will 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 Amsoki-cel (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, collaborative, innovative, passionate, and successful organization focused on delivering transformative therapies in areas of greatest clinical need.

• Deeply understand Obsidian’s viral vector, ancillary material and autologous cell therapy DP manufacturing processes to ensure exceptional manufacturing success rates, product consistency, and on-time delivery.
• Oversee execution of viral vector and ancillary drug substance manufacturing across a network of CDMO partners to ensure supply chain continuity and high-quality supply to the clinic
• Manage or collaborate on critical CDMO investigations, technical batch record review, M / E  revisions, change controls and continuous improvement projects as needed to enable exceptional manufacturing success rate, on time production and lot disposition.
• Oversee CDMO performance metrics for manufacturing and internal stakeholders, driving understanding of operational strengths, outcomes of strategic initiativese and continuous improvement opportunities
• Ensure ongoing operational readiness at CDMOs with a focus on operator training, suite/ equipment readiness, solution preparation and on the…