AnalyticalDevelopment Scientist – Biological Methods
hace 7 días
Analytical Development Scientist – Biological MethodsAsegúrese de presentar su candidatura con toda la información solicitada, tal como se expone en la descripción del puesto a continuación.Applications to be sent to: Global ResponsibilityResponsible for the execution, documentation, and technical integrity of analytical activities related to the development of bioanalytical methods within the organization.This includes ensuring that all analytical work—method development, validation, transfer, and routine support—is performed in compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), data integrity standards (ALCOA+), and internal Quality Management Systems (QMS).Specific ResponsibilitiesReview the documentation associated as well as documentation of reports, in accordance with GMP standards. Approve the analytical documentationPreparation of presentations and reports results and communicating with the relevant people involvedAnalyze samples of finished product and raw intermediate materials if necessaryProduce documentation required by the Quality SystemReview the work performed by the analysts and correct deviations from the established methodology.Write protocols to describe how to perform the activities requiredWrite a transfer and verification protocols and reports and coordinate the analysisOrganize and might perform Training of new analysts.Manage priorities of analytical projects assigned.Write procedures and analytical methods for its use in the Biological LaboratoryContribute and design practices for the good functioning of the laboratoryWrite technical SOPs when required and participate in their continuous review.Experience and Personal SkillsEducation:A bachelor´s degree in sciences. A PhD would be a plus.Languages:Fluent English and Fluent Spanish.Experience:3-5 years (Senior Scientist) of experience as an analytical scientist in R&D, pharma industry. Expert in LC-MS and QTOF (essential requirement), development and validation of biological methods (peptides, proteins, antibodies), processing of samples from plasma, serum, and other blood-derived fluids, experience in the pharmaceutical industry and GMP environments.Personal skills:Resolution, good organizational skills, persistency and autonomy. Able to work independently, prioritize and meet project timelines, be strongly self-motivated and able to motivate a team. Ability to work in a fast-paced environment and manage multiple competing demands.Additional InformationInnovation, customer orientation, communication, team work, adaptability/flexibility, productivity, self-development, sense of urgency, initiative.Experience in GMP environment, knowledge of ICH, FDA and EMEA regulatory guidances is a plus. xsgfvud Knowledge of: Peptide mapping -peptidomics-, disulfide bridge analysis, glycosylation characterization, absolute quantification of proteins.Seniority levelMid-Senior levelEmployment typeFull-timeIndustriesPharmaceutical Manufacturing#J-18808-Ljbffr
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