Senior Bioassay Scientist - CGT/ATMP Analytics (Remote)

Chiesi; Cagliari; 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 seeks an experienced analytical development leader to drive bioanalytical and potency assay strategies for gene editing and nucleic acid therapeutics. The role oversees outsourced activities, ensures data quality, and contributes to regulatory documentation in a global matrix environment.

Ideal candidates hold an MSc in biotechnology or related field with 5–10 years in biotech/pharma, strong cell-based assay skills, and GMP/CMC lifecycle knowledge.

Competenze

• Experience in analytical development for biotech/pharma.
• Strong knowledge of GMP/CMC and regulatory documentation.
• Proven track record in method development and validation.
• Experience managing outsourced analytical development.
• Excellent communication 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

Strong communication

Problem-solving mindset

Regulatory writing

Cross-functional collaboration

Cell-based assays

Potency assay development

Gene editing readouts

LNP/nucleic acid analytics

Analytical method development

GMP/CMC knowledge

CRO/CDMO management

Formazione

MSc in Biotechnology or related field

Strumenti

Flow cytometry

Reporter assays

Gene editing readouts

Descrizione del lavoro

Chiesi seeks an experienced analytical development leader to drive bioanalytical and potency assay strategies for gene editing and nucleic acid therapeutics. The role oversees outsourced activities, ensures data quality, and contributes to regulatory documentation in a global matrix environment.

Ideal candidates hold an MSc in biotechnology or related field with 5–10 years in biotech/pharma, strong cell-based assay skills, and GMP/CMC lifecycle knowledge.