Quality Control Microbiology Principle Scientist
Core
Subject matter expert leading GMP microbiological testing, method transfers, validations, and quality investigations for product release and stability.
Role type
Principal Scientist (Quality Control Microbiology)
Builds
GMP-compliant microbiological test methods, validation protocols, and quality documentation for pharmaceutical products.
Domain
Biopharmaceuticals / Quality Control
Required skills
Microbiology expertise, GMP/cGMP compliance, Method validation, Root cause analysis, Regulatory interpretation, Data integrity, LIMS/ELN proficiency, Technical writing, Project management, Mentoring
Preferred skills
Biotechnology or cell therapy experience, MALDI-TOF technology, Complex change control management
Technologies
LIMS, ELN, MALDI-TOF
Responsibilities
Lead and execute method transfers, validations, and verifications of in-process and final product methods. Review GMP testing for product release, in-process testing, and stability programs. Author and review protocols, reports, and GMP documentation. Lead investigations, deviations, and CAPAs. Represent QC in regulatory inspections and cross-functional teams. Mentor laboratory colleagues on test methods and procedures.
Seniority
Principal, hands-on IC with strategic oversight