Senior CMC Operations Director
1 week ago
MEDIPOST America, Inc. is a pioneering organization in the field of umbilical cord blood banking and cellular therapies. Our mission is to create groundbreaking stem cell treatments aimed at combating degenerative conditions such as Alzheimer's disease, Diabetic Neuropathy, and Osteoarthritis.
Our flagship product, CARTISTEM, represents a significant advancement as the first stem cell therapy specifically designed for knee Osteoarthritis. With a track record of successfully treating over 28,000 patients in Korea, we are now poised to expand our reach into North America and Europe through strategic collaborations.
We are seeking a CMC Lead to oversee critical functions within our organization. This position will focus on 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 filings. Key responsibilities include:
- Overseeing technology transfer and production workflows
- Crafting and implementing comprehensive CMC strategies
- Establishing a robust manufacturing framework
- Collaborating across various departments to ensure alignment
Additional Responsibilities:
- Advancing CMC capabilities within the organization
- Integrating operational strategies for efficiency
- Applying a quality by design approach to all processes
- Attracting and nurturing talent within the team
- Ensuring adherence to compliance and safety standards
Qualifications:
- A Bachelor’s degree in a relevant discipline; an advanced degree is preferred
- Significant experience in CMC drug development
- Familiarity with current Good Manufacturing Practices (cGMP) and regulatory guidelines
- Proven leadership experience in managing teams and projects
- Experience in the manufacturing of cell therapies
- Strong communication and interpersonal skills
- Willingness to travel as necessary
Become a part of MEDIPOST America, Inc. and contribute to the evolution of healthcare through innovative cell therapy solutions.
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