Senior Analytical Scientist - LNP/RNA analytics

This is what you will do

Chiesi-Global Rare disease is recruiting for a Senior Analytical Scientist with deep expertise in development, optimization, and validation of complex analytical methods for the characterization of ATMP including oligonucleotides, mRNA lipid nanoparticle (LNP) based products and other modalities.

In this role, you will be  a key member of the CMC Extended Technical Team (ETT) , operating in a matrix organisation and responsible for driving analytical development and control strategy for gene editing products within the GRD function from candidate selection though clinical development and toward commercial launch, while also supporting lifecycle management activities.

You will be responsible for

• Define and lead the development plan for analytical techniques used for RNA and nanoparticle characterization, including LC‑MS, HPLC‑CAD, DLS, electrophoretic methods and sequencing acting as a subject matter expert (SME) in method development, validations and control strategies for the assigned projects
• Design and oversee method development, qualification, validation, and product characterization.
• Develop a robust control strategies for mRNA–LNP products and modaliies (critical quality attributes, CQAs)
• Act as primary analytical lead for outsourced activities, including:
  • Selection and onboarding of CROs/CDMOs, including support in auditing and qualification
  • Technical oversight and governance of external partners ensuring robust and scientifically sound follow-up of external activities, driving accountability and continuous improvement.
  • Proactive troubleshooting and risk management  
  • Review of critical protocol, methods and data generated at the CDMO
  • Manage analytical project budgets (CROs, CDMOs, consultants).
• Actively contributing to the advancement of the project being a key player within the CMC team  and ensuring compliance with overall program, budget and regulatory strategy
• Write, review, and approve technical documentation within the area of responsibility, including development protocols and reports, stability studies , deviation assessments, and relevant regulatory sections (IND, IMPD, IB)

• Actively contributing to the development of the department in line with GRD and GRD R&D strategic goals, sharing knowledge, and best practices.

You will need to have

• Minimum MSc in relevant field (biotechnology, biochemistry, analytical chemistry, chemical engineering or a related field)
• 5-10 years of of experience in the biotech/pharmaceutical industry, with exposure to gene editing, CGT/ATMPs, nucleic acid-based products and lipid nano particles development
• Strong expertise in analytical methods and instruments for lipids, nanoparticle and nucleic acids characterization such as (critical requirement):
  • UPLC/UHPLC method development for lipids and oligonucleotides;
  • Ion-pair reversed-phase (IP-RP) chromatography;
  • Size-exclusion chromatography (SEC) for LNP size and aggregation profiling
  • DLS
  • LC-MS, high resolution MS
  • Next-generation sequencing (NGS) or Sanger sequencing
  • UV-Vis spectroscopy( Nanodrop)
  • Electrophoretic methods : Capillary electrophoresis (CE-SDS, CE-UV), Gel electrophoresis (agarose, PAGE) and Fragment analysis and charge heterogeneity profiling
  • Analytical method development, validation, and product characterization
  • Control strategy development for complex biologics
• Proven experience managing outsourced analytical development activities (CROs/CDMOs), including:
  • Technical oversight
  • Troubleshooting and escalation management
  • Critical, data-driven performance follow-up
• Solid understanding of GMP, regulatory requirements, and CMC development lifecycle.
• Demonstrated ability to operate effectively in a matrix organization and influence cross-functional teams.
• Strong skills in technical writing, data review, and regulatory documentation.
• Excellent problem-solving mindset with a hands-on, pragmatic, and results-driven approach.
• Strong communication and stakeholder management skills in an international environment.

Location

This position can be based anywhere in Europe, with both hybrid and remote options. 

Compensation range