Source Job

US

  • Provide strategic and technical leadership for CMC activities, overseeing technology transfer, scale-up, and cGMP manufacturing for small molecule drug development.
  • Manage contract manufacturing organizations and author regulatory submission sections to ensure alignment and timely achievement of program milestones.
  • Collaborate cross-functionally with Quality, Regulatory Affairs, and Supply Chain to support clinical and commercial goals from Phase I through commercialization.

Regulatory Submissions

2 jobs similar to Associate Director, Technical Operations CMC Strategy

Jobs ranked by similarity.

  • Lead day-to-day oversight of commercial manufacturing operations, process engineering activities, and continuous improvement initiatives.
  • Drive process optimization, troubleshooting, scale-up, PPQ, validation, and lifecycle management activities for commercial products.
  • Support regulatory CMC strategy, including development and review of Module 3 CTD submissions and health authority responses.

Deciphera Pharmaceuticals is committed to improve the lives of people with cancer. They offer a dynamic team environment and opportunities for personal and professional growth.

Global

  • Lead the Manufacturing and Supply Chain function, partnering with external providers and internalizing capabilities to advance the pipeline.
  • Evaluate, source, and manage contract manufacturers and supply organizations for autologous and allogeneic CAR T therapies globally.
  • Manage clinical supply, materials management, and strategic sourcing while ensuring network readiness for pivotal studies and commercial launch.

Kyverna is a cell therapy company engineering and developing curative living medicines for inflammatory and autoimmune diseases. The company is building on oncology CAR T technology and values intellectual humility, elevating each other, and staying true to why.