Analytical Sciences Data Review Group Leader
Core
Lead and manage a team of data reviewers to ensure GMP compliance and data quality for analytical testing.
Role type
Senior IC data review group leader
Builds
GMP-compliant analytical data packages for biopharmaceutical clients
Domain
Biopharmaceuticals / Analytical Sciences
Deliverable
client delivery
Required skills
cGMP data review, HPLC/UPLC data analysis, team leadership, logbook verification, chain of custody management, audit trail review, Good Documentation Practices (GDP), laboratory safety compliance, hiring and onboarding, productivity metric reporting
Preferred skills
ELISA, MCE, iCIEF exposure
Technologies
HPLC, UPLC, UV-Vis, LC, ELISA, MCE, iCIEF
Responsibilities
Review GMP analytical data for accuracy and compliance; verify logbook entries and chain of custody; review audit trails; lead and develop a team of data reviewers; coordinate workload and capacity planning; conduct safety walkthroughs; participate in hiring and training; report productivity and quality metrics
Seniority
Senior, hands-on IC with leadership