Study Lead - Extractable & Leachables
Core
Managing routine Extractables & Leachables (E&L) studies, overseeing testing, troubleshooting, and data integrity for pharmaceutical clients.
Role type
Senior IC analytical study lead (E&L/Mass Spec)
Builds
Routine study outputs (release, stability, quality control) for pharmaceutical companies
Domain
Pharmaceutical industry + Analytical Chemistry
Required skills
HPLC, GC, GC-MS, LC-MS, E&L sample preparation, study design, analytical method validation, GMP compliance, data integrity, risk assessment, mentoring
Preferred skills
ICP-MS
Technologies
LCMS-QQQ/Sciex 6500, Orbitrap, data collection software
Responsibilities
Manage multiple routine E&L projects and timelines; review and evaluate data; write scientific reports and protocols; provide guidance and training to laboratory staff; monitor daily operations for SOP and regulatory adherence; support audit readiness and client audits; escalate non-routine or complex issues to senior staff.
Seniority
Senior, hands-on IC
