Senior Analytical Scientist
Pubblicato il 30-08-2026 - Biotecnologie - Farmacia - Chimica in Italia
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, CE‐UV, gel electrophoresis