Scientist Product Characterization

Develop and qualify robust, fit-for-purpose analytical mass-spectrometry methods and optimize existing LC-MS and LC-MS/MS methods to support development activities of Recombinant Product DevelopmentExecute method development, qualification and/or optimization studies following QbD principles where applicablePrepare assay test procedures and assay qualification protocols for new test methods for approval by a Senior Scientist/Manager (e.g. peptide mapping, intact mass and middle down)Plan and execute analytical studies/ routine MS-analyses to support process development activities, product comparison and physico-chemical characterization activities (e.g. Comparability Studies, Forced Degradation Studies)When required perform routine analysis of samples using assays such as (but not limited to) SDS-PAGE, Western Blots, HPLC based assays (e.g. SE-HPLC, RP-HPLC, AIX-HPLC), glyco-profilingPrepare scientific reports detailing assay development and qualification studies or other analytical studies and present analytical data to key stakeholdersImplement and support quality systems within the group and ensure department compliance with scientific standardsSupport the maintenance of laboratory and analytical equipment. Liaise with instrument engineers and/or external service providers for maintenance of equipmentParticipate in the selection of equipment for purchase, write user requirements and prepare purchase ordersFollow safety standards as governed by local, state and federal regulations, laws and policies as well as companiy policies and directives. A University Degree in a relevant field of science (e.g. Bachelor of Science or Master of Science in Biochemistry / Protein Chemistry / Pharmacy)Project experience and knowledge of relevant analytical methodsEnglish fluent First experiences in relevant biopharma industry
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