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Senior CMC Director

2 months ago

Cambridge, Massachusetts, United States MEDIPOST America, Inc. Full time

MEDIPOST America, Inc. is a prominent umbilical cord blood banking and cellular therapy organization. Our mission is to pioneer advanced stem cell treatments aimed at combating degenerative conditions such as Alzheimer's disease, Diabetic Neuropathy, and Osteoarthritis.

Our flagship product, CARTISTEM, represents the first-ever stem cell therapy designed for knee Osteoarthritis. We have successfully treated over 28,000 patients in Korea and are currently broadening our reach into North America and Europe through a strategic partnership with Omniabio.

We are in search of a CMC Lead to oversee critical functions within our organization. This position will focus on steering technology transfer to our commercial Contract Development and Manufacturing Organization (CDMO), managing production for Phase III clinical trials, and formulating CMC strategies for regulatory submissions. Key responsibilities include:

  • Overseeing technology transfer and production workflows
  • Crafting and implementing CMC strategies
  • Establishing a robust manufacturing framework
  • Collaborating across various departments

Additional Responsibilities:

  • Enhancing CMC operational capabilities
  • Integrating comprehensive strategies
  • Applying a quality by design methodology
  • Recruiting and nurturing talent
  • Ensuring adherence to compliance and safety standards

Qualifications:

  • Bachelor's degree in a relevant discipline; advanced degree is preferred
  • Significant experience in CMC Drug Development
  • Familiarity with cGMP and regulatory frameworks
  • Proven leadership in managing teams and projects
  • Experience in the manufacturing of cell therapies
  • Exceptional communication abilities
  • Willingness to travel as necessary

Become a part of MEDIPOST America, Inc. and contribute to the evolution of healthcare through innovative cellular therapy solutions.