Senior Analytical Scientist
Pubblicato il 03-09-2026 - Chiesi Farmaceutici in Parma
Senior Analytical Scientist – LNP/RNA Analytics
Location: Parma, Italy (remote/hybrid options across Europe)
Business Area: R&D;, Pharmacovigilance & Regulatory Affairs
Job Type: Direct Employee – Permanent
Responsibilities
- 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; act as SME in method development, validation, and control strategies.
- Design and oversee method development, qualification, validation, and product characterization.
- Develop robust control strategies for mRNA‑LNP products and modalities (critical quality attributes, CQAs).
- Serve as primary analytical lead for outsourced activities, including selection and onboarding of CROs/CDMOs, technical oversight and governance to ensure robust, scientifically sound follow‑up, proactive troubleshooting, risk management, and review of critical protocol, methods, and data.
- Manage analytical project budgets (CROs, CDMOs, consultants).
- Contribute to program compliance, budget,
and regulatory strategy within the CMC team.
- Write, review, and approve technical documentation, including development protocols, reports, stability studies, deviation assessments, and regulatory sections (IND, IMPD, IB).
- Support the development of the department by sharing knowledge and best practices.
Qualifications
- Minimum MSc in biotechnology, biochemistry, analytical chemistry, chemical engineering or related field.
- 5–10 years of experience in the biotech/pharmaceutical industry with exposure to gene editing, CGT/ATMPs, nucleic acid–based products, and lipid nano‑particle development.
- Strong expertise with analytical methods and instruments for lipids, nanoparticle and nucleic acid characterization, including but not limited to UPLC/UHPLC, IP‑RP chromatography, SEC, DLS, LC‑MS, high‑resolution MS, NGS or Sanger sequencing, UV‑Vis spectroscopy, and electrophoretic methods (CE‑SDS, C