Senior Scientist, Quality Control
Core
Lead end-to-end Quality Control oversight for assigned biologic products, managing analytical methods, testing strategies, and regulatory submissions.
Role type
Senior Scientist, Quality Control (Biologics)
Builds
Commercial biologic products
Domain
Biopharmaceuticals / Biologics
Required skills
GMP principles, analytical method validation, stability testing, regulatory submission support, contract laboratory management, deviation investigation, change control, cross-functional collaboration
Preferred skills
Commercial QC best practices, complex problem solving, strategic vision for QC functions, influence across functions
Technologies
HPLC, LC-MS, GC-MS, stability chambers, LIMS, GMP documentation systems
Responsibilities
Provide end-to-end QC oversight for assigned products; Lead oversight of contract testing laboratory activities; Lead lifecycle management of analytical methods; Provide QC input for regulatory submissions; Coordinate review of commercial specifications; Partner cross-functionally to manage QC risks and issues; Author and maintain GMP documentation
Seniority
Senior, hands-on IC with leadership responsibilities
