At MilliporeSigma, as a Scientist 1 - Analytical Development, you will be the primary scientific resource for a given study with the Product Characterization Laboratory in our Biologics department.
The Scientist will act as subject matter expert in analytical method development and validation for testing required to manufacture clinical and commercial products.
Ensure current regulatory requirements and technical needs of internal and external clients are appropriately metDevelop / validate and perform analytical methods for GMP testingPrepare / review protocols and final reportsServe as study director and ensure timely initiation and completion of development / validation studiesParticipate in and / or drive assay development and / or assay validation activitiesResolve deviations by completing event recordsResponsible for creating / revising SOPs, laboratory records and other related documentationContributes ideas and suggestions to improve standard laboratory techniques, protocols, processes, and equipmentWho You Are : Minimum Qualifications : Ph.
D. in a scientific discipline (e.g., Biology, Microbiology, Chemistry, etc.), with 1+ years industry experience -OR-Master’s Degree in a scientific discipline (e.
g., Biology, Microbiology, Chemistry, etc.), with 2+ years industry experience -OR-Bachelor’s Degree in a scientific discipline (e.
g., Biology, Microbiology, Chemistry, etc.), with 5+ years industry experience Preferred Qualifications : Experience with some or all of the following technical disciplines Capillary Electrophoresis Methods (CE-SDS, cIEF)Liquid Chromatography (SEC, RP, IEX, etc.
Mass Spectrometry performing the following tests;Intact Molecular weightPeptide mappingDisulfide mappingGlycan ProfilingN- / C-Terminal SequencingExperience of method development in a pharmaceutical laboratory or similar fieldUnderstanding of GMP requirements for validation and documentationExcellent time management skills have been demonstrated through oversight of projectsHighly collaborative as well as independent, demonstrating a high level of initiativeExcellent verbal and written communication skills
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