Cmc Biologics Analytical Principal Scientist

hace 6 días


Madrid, España Almirall Hermal Gmbh A tiempo completo

Select how often (in days) to receive an alert:CMC Biologics Analytical Principal Scientist Mission Lead the analytical strategy for early/late programs.Day-to-day oversight of analytical activities performed at partnered CDMOs and CROs according to latest industry standards and regulatory guidance.Contribution to set up and development of in-house/outsourced analytical activitiesDefinition of DS & DP specification according to applicable regulatory guidelinesPrepare the plan for stability studies, reference standard, comparability studiesPrepare and/or review technical documents including method development, method validation, transfer protocols and reports.Authoring and review of CMC regulatory analytical submissions documentsWork closely with Drug Substance, Drug Product and Characterization Subject Matter Experts to develop analytical, characterization and comparability strategiesSupport defining/refining required processes for analytical/characterization activitiesExperience with analytical methods for GMP manufacturingUnderstanding of the detailed requirements for analytical validation and up to date with current trendsMight include CMC leadership activities.Education and Experience 15+ years of experience in the pharmaceutical industry focusing in analytical development.Experience in managing external and internal activities.Experience in data analysis and statistics.Experience with NBEs is preferred.Knowledge of GMP, GLP, GCP, Regulatory processes, a plus.Strong collaboration skills and experience working with external partnersCommunication skills in English written and oralValues Care: we listen & empathize, we value diverse perspectives & backgrounds and we help each other succeed.Courage: we challenge the status quo, we take full ownership and we learn from our success & failuresInnovation: we put the patient and customer at the center, we create novel solutions and we empower entrepreneurial mindsets.Simplicity : we act decisively and avoid over-analysis, we understand why before we act and we are agile & keep things simple.#J-18808-Ljbffr



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