Senior Bioassay Scientist for CGT/ATMP Analytics (Remote)

Chiesi; Lazio; Ibrido; EUR 110.000 - 170.000; 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 development leader to drive bioanalytical strategy for gene editing and nucleic acid therapeutics. You will oversee method development, validation, and control strategies, coordinating with CROs/CDMOs and cross-functional teams in a global matrix environment.

The role focuses on GMP-compliant assay development across early to late-stage programs. You will contribute to regulatory documentation and ensure high-quality data, with a strong emphasis on

Competenze

• MSc in biotechnology, biology, biochemistry or related field.
• 5–10 years in biotech/pharma with exposure to gene editing, CGT/ATMPs, nucleic acid-based products and LNPs.
• Strong expertise in cell-based assays and potency method development for gene editing or mRNA-LNP products.
• Advanced bioanalytical techniques (flow cytometry, reporter assays, gene editing readouts, binding and expression assays).
• Statistical tools for assay performance and reference standard qualification.
• Analytical method development, validation, and product characterization.
• GMP/CMC development lifecycle knowledge and regulatory documentation experience.
• Experience managing outsourced analytical development (CROs/CDMOs).
• Excellent communication, regulatory writing, and cross-functional collaboration skills.

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 assays and functional assays for gene editing efficiency.
• Implement assay 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 technical documentation (development protocols, reports, regulatory sections).

Conoscenze

Cell-based assays

Potency assay development

Gene editing readouts

Flow cytometry

Reporter assays

LNP/nucleic acid analytics

Analytical method development

Regulatory writing

Cross-functional collaboration

GMP/CMC knowledge

Formazione

MSc in biotechnology/biology/biochemistry

Descrizione del lavoro

Chiesi is seeking a senior analytical development leader to drive bioanalytical strategy for gene editing and nucleic acid therapeutics. You will oversee method development, validation, and control strategies, coordinating with CROs/CDMOs and cross-functional teams in a global matrix environment.

The role focuses on GMP-compliant assay development across early to late-stage programs. You will contribute to regulatory documentation and ensure high-quality data, with a strong emphasis on