13 ago
|
Chiesi Farmaceutici
|
Parma
13 ago
Chiesi Farmaceutici
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, CE‐U
📌 Senior Analytical Scientist (Parma)
🏢 Chiesi Farmaceutici
📍 Parma