Senior Analytical Scientist, mRNA LNP & CGT Analytics

Chiesi Group; Brussel; Híbrido; EUR 59 000 - 74 000; Tempo integral

Resumo da oferta

Chiesi Global Rare Diseases is seeking a Senior Analytical Scientist to lead development, optimization and validation of analytical methods for ATMPs, including RNA/LNP products. You will work in a matrix organization within the CMC Extended Technical Team, driving analytical development from candidate selection through clinical development toward launch.

The role requires MSc and 5–10 years biotech/pharma experience, strong GMP knowledge, and proven management of CRO/CDMO activities.

Qualificações

• MSc in biotechnology, biochemistry, analytical chemistry or a related field.
• 5–10 years of biotech/pharma experience with CGT/ATMPs, nucleic acids, and lipid nanoparticles.
• Strong expertise in analytical methods and instruments for lipids, nucleic acids, and nanoparticles.
• Experience managing outsourced analytical development (CROs/CDMOs) with oversight.
• Solid GMP/regulatory knowledge and matrix-team collaboration.

Responsabilidades

• Define and lead development plans for RNA and nanoparticle characterization methods.
• Design, qualification, validation, and product characterization of analytical methods.
• Develop robust control strategies for mRNA–LNP products and modalities.
• Act as analytical lead for outsourced activities including CRO/CDMO selection and oversight.
• Write, review and approve technical documents and regulatory sections.
• Contribute to GRD/CMC strategic goals and knowledge sharing.

Conhecimentos

Analytical method development

GMP/CMC knowledge

Outsourced analytics management

LC-MS

UHPLC

DLS

NGS/Sanger sequencing

Regulatory documentation

Technical writing

Cross-functional collaboration

Problem solving

Matrix organization

Biotech/pharma experience

Formação académica

Master of Science in Biotechnology/Biochemistry/Analytical Chemistry

Ferramentas

LC-MS

UHPLC

SEC

DLS

Capillary electrophoresis

UV-Vis (Nanodrop)

NGS

Descrição da oferta de emprego

Chiesi Global Rare Diseases is seeking a Senior Analytical Scientist to lead development, optimization and validation of analytical methods for ATMPs, including RNA/LNP products. You will work in a matrix organization within the CMC Extended Technical Team, driving analytical development from candidate selection through clinical development toward launch.

The role requires MSc and 5–10 years biotech/pharma experience, strong GMP knowledge, and proven management of CRO/CDMO activities.