Principle Process Engineer, Viral Vector Process Characterization and Commercialization
Core
Lead late-phase process development, validation, and commercialization of viral vector manufacturing processes, ensuring PPQ readiness and regulatory submission quality.
Role type
Principal Process Engineer (Viral Vector)
Builds
Viral vector drug substance and drug product manufacturing processes
Domain
Biopharmaceuticals / Viral Vectors
Required skills
Viral vector process development, Process characterization, Process validation, CMC authoring, Control strategy development, Risk assessment, Technology transfer, Regulatory inspection readiness, Data analysis, Technical documentation
Preferred skills
None stated
Technologies
None stated
Responsibilities
Lead design and execution of process characterization and validation studies for viral vector manufacturing. Develop and maintain science- and risk-based approaches for process parameter classification and control strategy. Independently author CMC sections for BLAs and global marketing applications. Partner with internal sites and external CMOs/CDMOs for technology transfer and commercial readiness. Support post-approval lifecycle management and comparability assessments. Mentor less experienced scientists and engineers.
Seniority
Principal, hands-on IC with mentorship