QCAT Senior Scientist:in (m/w/x) R-290142
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 study protocols for therapeutic products
Domain
Life Sciences / Pharmaceutical Quality Control
Required skills
Analytical method validation, Project planning, GMP compliance, Technical documentation, Team collaboration, Experimental design
Preferred skills
Experience with coagulation analyzers (BCS XP, Sysmex SC, Sysmex CN), Method transfer
Technologies
BCS XP, Sysmex SC, Sysmex CN
Responsibilities
Plan and execute analytical method validations including pre-studies and experiments; Plan and conduct projects for implementing new methods and improving existing ones; Create project plans estimating effort, materials, time, and costs; Support regulatory submissions as a subject matter expert; Create, review, and update documents (SOPs, test instructions, study plans); Provide technical guidance to local and global colleagues
Seniority
Senior, hands-on IC
