Analyst, Quality Control, Microbiology
Core
Perform routine environmental monitoring, water sampling, and GMP QC microbiological testing (sterility, bioburden, endotoxin) for mRNA drug products.
Role type
QC Microbiology Analyst (hands-on IC)
Builds
GMP-compliant drug substances and drug products (mRNA)
Domain
Biopharma / mRNA manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Microbiology testing techniques (Vitek, Isolator Technology, Bioburden, BET, Sterility), GMP compliance, cGMP regulations, data integrity, investigation skills, SOP authoring
Preferred skills
FDA/EU/ICH guidelines knowledge, method transfer experience, LIMS proficiency
Technologies
LIMS, Vitek, Isolator Technology
Responsibilities
Perform environmental monitoring and critical utility sampling; Execute sterility, bioburden, and endotoxin testing; Support release and stability testing; Collaborate on method transfers and validations; Author quality systems records (deviations, CAPAs, SOPs); Maintain laboratory equipment and reagents.
Seniority
Junior to Mid-level, hands-on IC