Social network you want to login/join with:Principal Extractable and Leachable Scientist, ParmaClient: Chiesi GroupLocation: Parma, ItalyJob Category: Other-EU work permit required: YesJob Reference: 61eb8a19f941Job Views: 6Posted: 18.06.2025Expiry Date: 02.08.2025Job Description:Who we are looking forPurposeThe Principal Extractable and Leachable Scientist will lead and manage extractable and leachable programs to ensure drug product safety and compliance. This role requires at least 5 years of experience in extractable and leachable testing, acting as a technical expert and guiding cross-functional teams.Main ResponsibilitiesDesign and implement E&L strategies for multiple projectsDevelop and validate analytical methods for E&L testingOversee E&L studies at CROsDraft, review, and approve testing protocols and reportsPrepare safety assessment summaries for regulatory submissionsCollaborate with suppliers and manufacturing to establish safety-based acceptance criteriaSupport regulatory interactions and responsesManage relationships with CROs and suppliersCommunicate project status effectively within teamsStay updated on industry trends and regulationsPreferred Experience RequiredExperience with pMDI inhalersExperience with foreign particulate matterExperience with elemental impurities (ICH Q3D)EducationMaster's degree in Pharmaceutical Sciences, Chemistry, Biological Sciences, or related field with 5+ years of experienceLanguages & Technical SkillsExtensive chromatography and mass spectrometry experience (GC/MS, LC/MS, ICP/MS)Experience with extractable and leachable testing methodsKnowledge of safety thresholds and best practicesUnderstanding of GMP/cGMP and relevant guidelines (ICH, EMEA, PQRI, Health Canada)Familiarity with pharmacopoeia standards (USP, Ph. Eur.)Proficiency in data analysis softwareAbility to interpret analytical results and identify trendsKnowledge of statistical methods (PCA, DoE)Soft SkillsLeadership and influencePlanning and organizationProblem solving and decision makingStrategic thinkingWhat we offerJoin a dynamic, fast-growing, and supportive environment. We invest in continuous training and development, promoting work-life balance through flexible and remote working options, relocation support, and other people-centric services.
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