QC Senior Scientist Functional Lead
Core
Lead QC projects for clinical and commercial biologics products, ensuring method readiness, validation, and timely delivery while serving as a trusted client advisor.
Role type
Senior IC QC Scientist / Project Lead
Builds
GMP-compliant testing protocols, validation data, and regulatory documentation for biologics
Domain
Biopharmaceuticals / Analytical Chemistry
Required skills
Project management, GMP regulations, biologics analytical techniques (HPLC/UPLC, CE, ELISA, Bioassays, PCR, SEC, icIEF), technology transfer, regulatory submissions
Preferred skills
Cross-functional collaboration, risk management, stakeholder communication
Technologies
HPLC, UPLC, CE, ELISA, Bioassays, PCR, SEC, icIEF
Responsibilities
Prepare and track QC project schedules including method qualification/validation/transfer; Monitor project progress and develop mitigation plans; Prepare GMP documents (release/stability protocols, sampling protocols); Support regulatory inspections, audits, and submissions with data and expertise
Seniority
Senior, hands-on IC with project leadership
