Dual-track adherent and suspension process development
Late-stage clinical or ppq experience in gene therapy
Scale-up and technology transfer execution
The role involves planning dual-path development strategies for both adherent and suspension processes while defining relationships between critical quality attributes and critical process parameters
Job Summary
The role involves planning dual-path development strategies for both adherent and suspension processes while defining relationships between critical quality attributes and critical process parameters.
Candidates must have at least four years of upstream process development experience specifically in gene therapy or viral vectors with late-stage or commercial support exposure.
The position requires leading scale-up strategies, executing engineering runs, and supporting the transfer of processes to internal GMP manufacturing or CDMOs.
Matching Summary
The role involves planning dual-path development strategies for both adherent and suspension processes while defining relationships between critical quality attributes and critical process parameters.
Skills & Requirements
Must-have
Dual-track adherent and suspension process development
Late-stage clinical or PPQ experience in gene therapy
Scale-up and technology transfer execution
Critical quality attributes and critical process parameters definition
Robustness-by-design implementation for upstream processes
GMP facility operations and single-use bioreactor platforms
DoE, multivariate analysis, and statistical analysis proficiency
Nice-to-have
Experience with stable packaging cell lines
Strong cross-functional collaboration skills
Ability to drive decisions under time pressure
Excellent English writing and communication skills
Experience leading deviation investigations and CAPA activities
Key Requirements
Master's degree in Bioengineering, Biopharmaceuticals, Cell Biology, or related field
4+ years of upstream process development experience in gene therapy
Proven track record of leading adherent and suspension scale-up projects
Hands-on experience with GMP facility operations and troubleshooting