OverviewLe interessa questa possibilità? Si candidi in fretta, è previsto un elevato volume di candidature. Scorra verso il basso per leggere la descrizione completa.In this role you drive analytical development for gene editing and nucleic acid-based therapeutics within the GRD CMC team. You lead method development and control strategies for complex modalities, including ATMPs and LNP-based products, collaborating across functions from candidate selection to clinical development and launch. You oversee outsourced activities, ensure data quality, and contribute to regulatory documentation. This position offers impact in shaping analytics for cutting-edge therapies in a global, matrix environment.Retribuzione / Benefitspensionprivate medical insurancewellbeing programmeflexible benefits programmeremote work optionsrelocation supportResponsabilitàDefine and lead bioanalytical and potency assay strategies for gene editing and nucleic acid therapeuticsAct as SME for method development, validation, and control strategies for assigned projectsDrive fit-for-purpose assay development from early to late-stage GMPDesign and oversee cell-based potency assays and functional assays for gene editing efficiencyImplement assay qualification/validation,



stability-indicating and comparability assaysLead outsourced analytical activities including CRO/CDMO selection and governanceProvide technical oversight of external partners and ensure robust follow-up of activitiesManage analytical project budgets for CROs/CDMOs and consultantsWrite and review technical documentation (development protocols, reports, regulatory sections)Requisiti fondamentaliMSc in biotechnology, biology, biochemistry or related field5–10 years in biotech/pharma with exposure to gene editing, CGT/ATMPs, nucleic acid-based products and LNPsStrong expertise in cell-based assays and potency method development for gene editing or mRNA–LNP productsAdvanced bioanalytical techniques (flow cytometry, reporter assays, gene editing readouts, binding and expression assays)Statistical tools xysqume for assay performance and reference standard qualificationAnalytical method development, validation, and product characterizationGMP/CMC development lifecycle knowledge and regulatory documentation experienceExperience managing outsourced analytical development (CROs/CDMOs)Excellent communication, regulatory writing, and cross-functional collaboration skillsHands-on, pragmatic, results-driven problem solverstrong communicationstakeholder managementproblem-solving mindsetcell-based assays and potency assay developmentgene editing readouts and delivery assaysLNP/nucleic acid-based product analytics

📌 Senior Analytical Scientist - Bioassay Cgt/Atmp (Treviso)
🏢 Chiesi
📍 Treviso