Senior Analytical Scientist - Bioassay Cgt/Atmp

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

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