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 Commercialization)
Builds
Viral vector drug substance and drug product manufacturing processes for biologics
Domain
Biopharmaceuticals / Viral Vector Manufacturing
Required skills
Viral vector manufacturing expertise, CMC regulatory authoring, process validation, control strategy development, risk management, technology transfer, GMP compliance, cross-functional collaboration
Preferred skills
Approved BLA/MAA authorship, Health Authority interaction experience, CMO/CDMO partnership management, post-approval change management
Technologies
GMP manufacturing platforms, upstream/downstream operations, fill-finish, analytical method integration
Responsibilities
Lead process characterization and validation studies for viral vectors; Independently author CMC sections for BLAs and MAAs; Partner with CMOs/CDMOs for technology transfer and PPQ execution; Support post-approval lifecycle management and comparability assessments; Mentor junior engineers without direct people management
Seniority
Principal, hands-on IC with strategic oversight