The Scientist, is part of Analytical Development Starting Material Group and will be responsible for Develop, qualify and transfer GC, HPLC, UPLC and mass spectrometry based assays of starting materials, raw materials, intermediates and excipients to suppliers, CMOs and QC.
Identify impurity profiles and provide data to set impurity limits.
Understand and apply advanced scientific principles, theories, concepts, practices and standards to process and analytical development.
Author and review method development and qualification reports and SOP s for test methods, as well as transfer / qualification protocols and reports related to critical starting materials / intermediates / excipients.
Provide analytical support externally and internally.
Qualifications
Ph.D. in Analytical Chemistry, Organic Chemistry or related disciplines with > 1 year biopharmaceutical experience or equiva...