QC Functional Lead
Core
Lead Quality Control (QC) projects for clinical and commercial biologics products, ensuring method readiness, validation, and timely delivery while serving as the primary client contact.
Role type
Senior QC Functional Lead (Biologics)
Builds
GMP-compliant testing protocols, validation data, and regulatory documentation for biologics products
Domain
Biopharmaceuticals / Analytical Chemistry
Required skills
Biologics analytical techniques (HPLC/UPLC, CE, ELISA, Bioassays, PCR, SEC, icIEF), GMP regulations, project management, technology transfer, regulatory inspection support, client relationship management
Preferred skills
Bachelor's, Master's, or PhD in Biochemistry, Biotechnology, Analytical Chemistry, or Pharmaceutical Sciences; 8+ years of GMP biologics QC experience