Senior Analytical Scientist - Bioassay Cgt/Atmp
Pubblicato il 26-09-2026 - Chiesi in Lazio
In this role you drive analytical development for gene editing and nucleic acid-based therapeutics within the GRD CMC team.
You lead method development and control strategies for complex modalities, including ATMPs and LNP-based products, collaborating across functions from candidate selection to clinical development and launch.
You oversee outsourced activities, ensure data quality, and contribute to regulatory documentation.
This position offers impact in shaping analytics for cutting-edge therapies in a global, matrix environment.
pension
private medical insurance
remote work options
relocation support
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)
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
strong communication
problem-solving mindset
cell-based assays and potency assay development
gene editing readouts and delivery assays
LNP/nucleic acid-based product analytics
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