Senior Analytical Scientist - LNP/RNA analytics
Chiesi
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
- 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
- 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
Offerta di lavoro pubblicata 2 giorni fa
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