Overview
As a Senior Analytical Scientist in Chiesi Global Rare Diseases, you lead analytical development for RNA and nanoparticle-based therapies, including mRNA-LNP products. You will shape the control strategy and act as SME for method development, validation, and compliance within the CMC Extended Technical Team. You'll manage outsourced analytical work with CROs/CDMOs and contribute to from-candidate selection through clinical development and launch. This role offers impact on cutting-edge gene-editing modalities within a collaborative, matrix environment.
Retribuzione / Benefits
pension
private medical insurance
wellbeing programme
flexible benefits programme
relocation support
remote work options
Responsabilità
Define and lead analytical development plans for RNA and nanoparticle characterization (LC-MS, HPLC-CAD, DLS, electrophoretic methods, sequencing)
Design, qualify, validate, and characterize analytical methods and products
Develop robust CQAs and control strategies for mRNA–LNP products
Manage outsourced analytical activities (CROs/CDMOs): selection, onboarding, audits, governance
Provide technical oversight and risk management for external partners and activities
Review critical protocols, methods and data from CDMOs; manage analytical project budgets
Contribute to overall program strategy, regulatory alignment (IND, IMPD, IB) and department development




Prepare and approve technical documents (development protocols, reports, stability studies, deviation assessments)
Support lifecycle activities and interactions with cross-functional teams in a matrix organization
Demonstrate strong GMP/regulatory understanding and effective stakeholder communication
Requisiti fondamentali
MSc in a relevant field
5-10 years in biotech/pharma with exposure to gene editing, CGT/ATMPs, nucleic acid products, and lipid nanoparticles
Strong expertise in analytical methods for lipids, nanoparticles, and nucleic acids (UPLC/UHPLC, IP-RP, SEC, DLS, LC-MS, high-res MS)
NGS or Sanger sequencing; UV-Vis spectroscopy
Electrophoretic methods (CE-SDS, CE-UV, agarose PAGE), fragmentation and charge heterogeneity profiling
Analytical method development, validation, and product characterization
Control strategy development for complex biologics and management of outsourced development
GMP/regulatory lifecycle knowledge; matrix organization experience
Strong technical writing, data review, and regulatory documentation; stakeholder management
Strong communication
Problem-solving mindset
Collaborative and cross-functional influence
UPLC/UHPLC method development for lipids and oligonucleotides
Ion-pair reversed-phase chromatography
SEC for LNP sizing and aggregation

📌 Senior Analytical Scientist - Lnp/Rna Analytics (Emilia-Romagna)
🏢 Chiesi
📍 Emilia-Romagna