Study Manager I, Extractable and Leachable
Core
Manage and coordinate Extractable and Leachable (E&L) testing projects, designing studies, writing protocols, and reviewing reports to ensure cGMP compliance.
Role type
Senior IC study manager (E&L testing)
Builds
E&L study protocols, reports, and testing results
Domain
Life Sciences / Regulatory Testing
Required skills
E&L project management, protocol design, report writing, cGMP compliance, client communication, HPLC/MS/GC/MS/ICP/MS instrumentation knowledge, GMP experience
Preferred skills
None stated
Technologies
HPLC/MS, GC/MS, ICP/MS
Responsibilities
Design E&L studies and write/review study protocols; Review testing results and compliance with quality criteria; Write/review study reports; Solve client questions and comments on reports; Coordinate E&L projects with clients as technical contact
Seniority
Mid-level, hands-on IC
