Senior Analytical Scientist - LNP/RNA analytics

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, PAGE, fragment analysis).
• Proven experience managing outsourced analytical development activities (CROs/CDMOs) with technical oversight, troubleshooting, escalation, and performance follow‑up.
• Solid understanding of GMP, regulatory requirements, and the CMC development life cycle.
• 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 and stakeholder‑management skills in an international environment.

Compensation and Benefits

Salary range: minimum €59 000, with additional annual bonus based on company and individual performance. Benefits include pension, private medical insurance, wellbeing programme, flexible benefits programme, and relocation support where applicable.

Equal Opportunity Statement

Chiesi is an equal‑opportunity employer committed to hiring a diverse workforce. All qualified applicants receive consideration for employment based on attitude and merit without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws.