ElevateBio is a technology-driven cell and gene therapy company that accelerates access to cutting-edge technologies and expertise to change the future of medicine. The Senior Manager, CMC Operations & Program Management will lead cross-functional activities between CMC groups and other departments at ElevateBio BaseCamp.
Requirements
- B.S. in a scientific or engineering discipline
- 8 or more years of relevant experience in the CMC environment
- Experience with tech transfers of advanced therapeutics and/or biologics
- cGMP product/program management experience
- Strong understanding of US FDA and EU EMA regulations and ICH guidelines for cell and gene therapy products
- Program management skills
- Strong verbal and written skills
- Effective interpersonal, technical, and troubleshooting skills