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Senior CMC Development 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, dedicated to pioneering innovative stem cell treatments for degenerative conditions such as Alzheimer's disease, Diabetic Neuropathy, and Osteoarthritis.

Our flagship product, CARTISTEM, represents the first stem cell therapy globally approved for knee Osteoarthritis. With over 28,000 patients treated in Korea, we are now broadening our reach into North America and Europe through a strategic partnership with Omniabio.

We are seeking a CMC Lead to oversee critical functions within our organization. This position will be responsible for facilitating technology transfer to our commercial contract development and manufacturing organization (CDMO), managing production processes for Phase III clinical trials, and formulating CMC strategies for regulatory submissions. Key responsibilities include:

  • Leading technology transfer and production operations
  • Formulating and executing CMC strategies
  • Establishing a robust manufacturing framework
  • Collaborating across various departments

Additional Responsibilities:

  • Enhancing CMC operational capabilities
  • Integrating comprehensive strategies
  • Implementing 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
  • In-depth knowledge of cGMP and regulatory standards
  • Proven leadership experience in team and project management
  • Experience in the manufacturing of cell therapies
  • Exceptional communication skills
  • Willingness to travel as necessary

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