Source Job

US

  • Lead operational oversight of clinical external manufacturing for drug product, transitioning monoclonal antibodies into scalable processes.
  • Develop robust aseptic strategies for vial and prefilled syringe formats, managing CMOs and technology transfers.
  • Collaborate with formulation and device teams to create stable high-concentration liquid formulations and troubleshoot manufacturing issues.

Regulatory Submissions

4 jobs similar to Associate Director/Director Drug Product, CMC

Jobs ranked by similarity.

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.

Travere Therapeutics is a biopharmaceutical company dedicated to identifying, developing, and delivering life-changing therapies for people living with rare disease. The company is a dedicated team focused on meeting the unique needs of rare patients, fostering a collaborative, diverse, and fast-paced environment centered on patients, courage, community, and collaboration.

USA Unlimited PTO

  • Oversee contract development organizations (CDMOs) to manage analytical development and quality control activities for drug substance and product.
  • Support and author analytical content for CMC Regulatory filings in the US and rest of world.
  • Manage GMP stability studies, reference standards, specifications, and analytical method development/validation.

BridgeBio is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines for genetic diseases and cancers with clear genetic drivers. Founded in 2015, the company has a portfolio of 20+ drug development programs and offices in the US, Canada, and Switzerland, focusing on scientific excellence and rapid execution.

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.

US

  • Lead integrated asset strategy across the full product lifecycle, from research through commercialization.
  • Drive strategic planning for emerging therapeutic platform technologies and evaluate portfolio opportunities.
  • Partner cross-functionally with Research, Clinical, Regulatory, and Commercial teams to ensure alignment and execution.

Kyverna Therapeutics is a clinical-stage biopharmaceutical company developing cell therapies for autoimmune diseases. Guided by core values, the company is committed to transforming treatment for autoimmune disease.