Senior Bioassay Scientist - CGT/ATMP Analytics Lead (Remote)

Chiesi; Monza; Ibrido; EUR 70.000 - 110.000; Tempo pieno

Vantaggi offerti da questo lavoro

Pension

Private medical insurance

Remote work options

Relocation support

Descrizione del lavoro

Chiesi is seeking a Senior Analytical Scientist - Bioassay CGT/ATMP in Monza, Lombardia. You will drive analytical development for gene editing and nucleic acid therapeutics, leading method development and control strategies across this cutting-edge portfolio.

You will oversee outsourced activities, ensure data quality, and contribute to regulatory documentation in a global matrix environment. A strong background in cell-based assays and GMP/CMC processes is essential.

Competenze

• MSc in biotechnology, biology, biochemistry or related field.
• 5–10 years in biotech/pharma with exposure to gene editing, CGT/ATMPs, nucleic acid products and LNPs.
• Strong expertise in cell-based assays and potency method development for gene editing or mRNA-LNP products.
• Experience leading outsourced analytical development (CROs/CDMOs).
• GMP/CMC development lifecycle knowledge and regulatory documentation experience.

Mansioni

• Define and lead bioanalytical and potency assay strategies for gene editing and nucleic acid therapeutics.
• Act as SME for method development, validation, and control strategies for assigned projects.
• Drive fit-for-purpose assay development from early to late-stage GMP.
• Design and oversee cell-based potency and functional assays for gene editing efficiency.
• Implement qualification/validation, stability-indicating and comparability assays.
• Lead outsourced analytical activities including CRO/CDMO selection and governance.
• Provide technical oversight of external partners and ensure robust follow-up of activities.
• Manage analytical project budgets for CROs/CDMOs and consultants.
• Write and review development protocols, reports, and regulatory sections.

Conoscenze

Bioassay development

CGT/ATMP analytics

Analytical method development

Flow cytometry

Gene editing readouts

LNP/nucleic acid analytics

Statistics for assay performance

Regulatory writing support

Cross-functional collaboration

Outsourced project oversight

Formazione

MSc in biotechnology/biology/biochemistry

Descrizione del lavoro

Chiesi is seeking a Senior Analytical Scientist - Bioassay CGT/ATMP in Monza, Lombardia. You will drive analytical development for gene editing and nucleic acid therapeutics, leading method development and control strategies across this cutting-edge portfolio.

You will oversee outsourced activities, ensure data quality, and contribute to regulatory documentation in a global matrix environment. A strong background in cell-based assays and GMP/CMC processes is essential.