Senior Analytical Scientist – RNA-LNP & CGT Analytics

Biopharma Careers; Parma; Ibrido; EUR 53.000 - 65.000; Tempo pieno

Vantaggi offerti da questo lavoro

Healthcare package

Relocation support

Flexible working

Descrizione del lavoro

Chiesi Global Rare Diseases is recruiting a Senior Analytical Scientist with deep expertise in development, optimization, and validation of complex analytical methods for ATMP including oligonucleotides and mRNA lipid nanoparticle (LNP) based products and other modalities.

You will be a key member of the CMC Extended Technical Team (ETT), operating in a matrix organisation and responsible for driving analytical development and control strategy from candidate selection through clinical

Competenze

• Minimum MSc in relevant field (biotechnology, biochemistry, analytical chemistry, chemical engineering or a related field)
• 5-10 years of experience in biotech/pharma with exposure to gene editing, CGT/ATMPs, nucleic acid-based products and lipid nanoparticles development
• Solid GMP knowledge and regulatory writing experience
• Demonstrated ability to lead analytical method development and external partner oversight

Mansioni

• Define and lead development plans for analytical techniques for RNA and nanoparticle characterization (LC-MS, HPLC-CAD, DLS)
• Design and oversee method development, qualification, validation, and product characterization
• Develop robust control strategies for mRNA–LNP products and modalities (CQAs)
• Act as analytical lead for outsourced activities (CROs/CDMOs) and ensure follow-up and governance
• Write, review and approve technical docs, protocols and reports including regulatory sections (IND, IMPD, IB)
• Manage analytical project budgets and contribute to GRD R&D goals

Conoscenze

Analytical methods

GMP awareness

Regulatory writing

Communication

Formazione

MSc in Biotechnology/Analytical chemistry

Strumenti

LC-MS

HPLC-CAD

DLS

NGS

UV-Vis

CE-SDS

Descrizione del lavoro

Chiesi Global Rare Diseases is recruiting a Senior Analytical Scientist with deep expertise in development, optimization, and validation of complex analytical methods for ATMP including oligonucleotides and mRNA lipid nanoparticle (LNP) based products and other modalities.

You will be a key member of the CMC Extended Technical Team (ETT), operating in a matrix organisation and responsible for driving analytical development and control strategy from candidate selection through clinical