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 (Senior IC)
Builds
GMP-compliant microbiological test methods and quality data for pharmaceutical products
Domain
Biopharmaceuticals / Microbiology / Quality Control
Required skills
Microbiology expertise, cGMP compliance, Method validation, Root cause analysis, CAPA management, LIMS/ELN proficiency, Regulatory interpretation, Technical writing, Cross-functional leadership, Project management
Preferred skills
Biotechnology or cell therapy experience, MALDI-TOF proficiency, STEM degree in Microbiology
Technologies
LIMS, ELN, MALDI-TOF
Responsibilities
Lead and execute method transfers and validations; Review GMP testing for product release and stability; Author and review protocols and GMP documentation; Lead investigations, deviations, and CAPAs; Mentor laboratory colleagues; Represent QC in regulatory inspections and cross-functional teams
Seniority
Principal, hands-on IC with strategic oversight