QC Analytical Technology Lead Scientist (m/w/x) R-290123
Core
Lead scientist for analytical method validation, optimization, and implementation in a GMP-regulated Quality Control environment, focusing on coagulation assays.
Role type
Senior IC analytical technology lead scientist (coagulation)
Builds
Validated analytical methods and coagulation assay protocols for therapeutic products
Domain
Life sciences / Clinical diagnostics / Coagulation
Required skills
Analytical method validation, Coagulation assay expertise, GMP compliance, Project management, Technical leadership, Data interpretation, SOP development, Regulatory knowledge, Team coaching, Process improvement
Preferred skills
Experience with BCS XP, Sysmex SC, Sysmex CN analyzers
Technologies
BCS XP, Sysmex SC, Sysmex CN
Responsibilities
Lead optimization, qualification, validation, and transfer of analytical methods; Coordinate creation and review of GMP documentation (SOPs, study plans); Ensure compliance with regulatory requirements; Lead interpretation and reporting of test results; Provide technical leadership and training for local and global QC colleagues; Manage complex local and global projects; Support colleagues with complex investigations and deviations; Prepare for and participate in regulatory inspections.
Seniority
Senior, hands-on IC with mentorship responsibilities
