Senior Analytical Scientist - Lnp/Rna Analytics

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ph3Senior Analytical Scientist – LNP/RNA Analytics /h3 pLocation: Parma, Italy (remote/hybrid options across Europe) /p pBusiness Area: RD, Pharmacovigilance Regulatory Affairsbr/Job Type: Direct Employee – Permanent /p h3Responsibilities /h3 ul liDefine 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.
/li liDesign and oversee method development, qualification, validation, and product characterization.
/li liDevelop robust control strategies for mRNA?LNP products and modalities (critical quality attributes, CQAs).
/li liServe 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.
/li liManage analytical project budgets (CROs, CDMOs, consultants).
/li liContribute to program compliance, budget, and regulatory strategy within the CMC team.
/li liWrite, review, and approve technical documentation, including development protocols, reports, stability studies, deviation assessments, and regulatory sections (IND, IMPD, IB).
/li liSupport the development of the department by sharing knowledge and best practices.
/li /ul h3Qualifications /h3 ul liMinimum MSc in biotechnology, biochemistry, analytical chemistry, chemical engineering or related field.
/li li5–10 years of experience in the biotech/pharmaceutical industry with exposure to gene editing, CGT/ATMPs, nucleic acid–based products,



and lipid nano?particle development.
/li liStrong 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).
/li liProven experience managing outsourced analytical development activities (CROs/CDMOs) with technical oversight, troubleshooting, escalation, and performance follow?up.
/li liSolid understanding of GMP, regulatory requirements, and the CMC development life cycle.
/li liDemonstrated ability to operate effectively in a matrix organization and influence cross?functional teams.
/li liStrong skills in technical writing, data review, and regulatory documentation.
/li liExcellent problem?solving mindset and stakeholder?management skills in an international environment.
/li /ul h3Compensation and Benefits /h3 pSalary range: minimum €******, with additional annual premio based on company and individual performance.
Benefits include pension, private medical insurance, wellbeing programme, flexible benefits programme, and relocation support where applicable.
/p h3Equal Opportunity Statement /h3 pChiesi 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.
/p /p #J-*****-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7f0gzt