The role provides technical leadership for viral vector manufacturing supporting in vivo programs across clinical development and commercial lifecycle management
Job Summary
The role provides technical leadership for viral vector manufacturing supporting in vivo programs across clinical development and commercial lifecycle management.
Candidates must own end-to-end process knowledge including upstream production, downstream purification, formulation, and fill/finish interfaces.
The position requires leading technology transfer of viral vector processes from Process Development into GMP manufacturing at internal or external sites.
Matching Summary
The role provides technical leadership for viral vector manufacturing supporting in vivo programs across clinical development and commercial lifecycle management.
Skills & Requirements
Must-have
Viral vector manufacturing expertise
Technology transfer to GMP sites
Root cause investigation and CAPA
CMC regulatory submission experience
Process characterization and control strategy
Nice-to-have
CAR-T cell therapy experience
Global commercial program management
CDMO collaboration skills
Team mentorship and development
Cross-functional partnership abilities
Key Requirements
Minimum 10 years MSAT or tech transfer experience
B.S. degree in biology, engineering, or science
Extensive cell therapy commercial cGMP program experience