Senior Scientist, Analytical Methods Transfer - (Morrisville, NC)

Overview The Analytical Method Transfer (AMT) group is seeking a Senior Scientist, program technical lead to manage the team-based execution of client-based projects. The AMT group is a protocol-driven group which primarily performs formal Tech Transfer, Qualification, Validation and Verification of test methods coming out of the development group and then transitions them into our Quality Control group. The position will primarily focus on creating analytical method protocols and summary reports (TT, qualification, validation and verification), oversee individuals executing protocols, review data, ensure a seamless transition to the QC group in a manner that sets them up for "right 1st time" and prolonged execution success, troubleshoot issues/spearhead investigations and work together with the QA group throughout. The applicant will be expected to follow cGMP documentation practices and initiate deviation, lab investigation, method revisions and other related activities within the quality system.