QCAT Senior Scientist:in (m/w/x) R-290140
Core
Conducting analytical method validations and implementing methods in a GMP-regulated environment for quality control.
Role type
Senior Scientist (Quality Control)
Builds
Validated analytical methods and quality control processes
Domain
Life Sciences / Biopharmaceuticals / Quality Control
Required skills
Analytical method validation, Project management, Coagulation assays, Coagulation analyzers (BCS XP, Sysmex SC, Sysmex CN), GMP environment, SOP creation
Preferred skills
Method transfer, Technical and scientific mentoring
Technologies
BCS XP, Sysmex SC, Sysmex CN
Responsibilities
Plan and execute analytical method validations including pre-tests and experiments for method transfer; Plan and execute projects and studies for implementing new methods, innovative technologies, and improving existing methods; Create project plans including estimating effort, materials, time, and costs; Participate in regulatory submissions and inquiries as a subject matter expert; Create, review, and revise documents (e.g., SOPs, test instructions, study plans, reports); Provide technical and scientific guidance to local and global colleagues
