Head of CMC Operations
1 week ago
MEDIPOST America, Inc. is a prominent entity in the field of umbilical cord blood banking and cellular therapy, dedicated to pioneering advanced stem cell treatments for degenerative conditions such as Alzheimer's disease, Diabetic Neuropathy, and Osteoarthritis.
Our flagship product, CARTISTEM, represents a groundbreaking stem cell therapy specifically designed for knee Osteoarthritis. With a successful track record of treating over 28,000 patients in Korea, we are now poised to expand our reach into North America and Europe through a strategic alliance with Omniabio.
We are seeking a CMC Lead to oversee critical operations. This position encompasses the management of technology transfer to our commercial contract development and manufacturing organization (CDMO), overseeing production for Phase III clinical trials, and formulating CMC strategies for regulatory submissions. Key responsibilities include:
- Directing technology transfer and production workflows
- Formulating and executing comprehensive CMC strategies
- Establishing a robust manufacturing framework
- Collaborating effectively across various departments
Additional Responsibilities:
- Advancing CMC capabilities
- Integrating strategic initiatives
- 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 advantageous
- Significant experience in CMC Drug Development
- Familiarity with cGMP and regulatory standards
- Proven leadership experience in team and project management
- Background in cell therapy manufacturing
- Exceptional communication abilities
- Willingness to travel as necessary
Become a part of MEDIPOST America, Inc. and contribute to the advancement of healthcare through innovative cell therapy solutions.
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Head of CMC Operations
2 weeks ago
Cambridge, Massachusetts, United States MEDIPOST America, Inc. Full timeMEDIPOST America, Inc. is a prominent umbilical cord blood banking and cellular therapy organization dedicated to pioneering advanced 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 specifically designed for knee...
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Head of CMC Operations
2 weeks ago
Cambridge, Massachusetts, United States MEDIPOST America, Inc. Full timeMEDIPOST America, Inc. is a prominent umbilical cord blood banking and cellular therapy organization, dedicated to pioneering advanced stem cell treatments for degenerative conditions such as Alzheimer's disease, Diabetic Neuropathy, and Osteoarthritis.Our flagship product, CARTISTEM, represents the first-ever stem cell therapy for knee Osteoarthritis...
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