Offer summary
Qualifications:
Doctoral degree in biochemical engineering, bioengineering or related field, At least 8 years of CMC experience with a preference for cell therapies, Proficiency in process development, regulatory and quality compliance, Experience in cGMP facilities and IND filing for biologics.
Key responsabilities:
- Enhance internal cell therapy CMC capability by collaborating with stakeholders
- Manage GTP/GMP facility and oversee clinical material production for trials
- Lead cross-functional teams for regulatory submission and product release
- Develop vendor selection strategies for development and manufacturing services