Senior Analytical Scientist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7b8soa

Experteer 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 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
Responsabilità 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 pr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7b8soa