Toxicology Scientist - Impurities & Genotoxicity Strategy

Excelya Group; Saclay; Sur place; EUR 70 000 - 100 000; Plein temps

Résumé du poste

Excelya is seeking a senior toxicology expert to join our drug development team in France. You will provide toxicology expertise for impurity assessment, genotoxicity strategies, and health-based exposure limits across preclinical to regulatory stages.

You will collaborate with CMC and external partners, develop risk assessments, contribute to regulatory documentation, and communicate strategies across cross-functional teams in a fast-paced, collaborative environment.

Qualifications

• Master's or PhD in Toxicology, Biology, Pharmacology, or related field.
• Experience in toxicology and pharmaceutical development is desirable.
• Strong knowledge of ICH Q3A/B/C and ICH M7.
• Experience with genotoxicity assessment strategies.
• Hands-on genotoxicity testing and in silico toxicology tools.
• Fluent English (written and spoken).

Responsabilités

• Support non-clinical safety strategies related to drug impurities, extractables & leachables, and genotoxic impurities.
• Assess and qualify impurities throughout the drug development lifecycle per ICH Q3A/B/C and ICH M7.
• Develop impurity risk assessments and support safety evaluations.
• Prepare regulatory documentation and scientific justifications.
• Provide toxicology expertise for management of potential genotoxic impurities.
• Calculate PDEs and other health-based exposure limits.
• Support occupational toxicology activities, including derivation of occupational exposure limits.
• Collaborate with CMC teams, external partners, and cross-functional project stakeholders.
• Communicate toxicology strategies across project teams.

Connaissances

Impurity assessment

Genotoxicity strategies

ICH Q3A/B/C

ICH M7 guidelines

PDE calculations

Toxicology expertise

Cross-functional communication

Fluent English

Formation

Master's degree in Toxicology

PhD in Toxicology

Outils

Genotoxicity testing

In silico toxicology tools

Description du poste

Excelya is seeking a senior toxicology expert to join our drug development team in France. You will provide toxicology expertise for impurity assessment, genotoxicity strategies, and health-based exposure limits across preclinical to regulatory stages.

You will collaborate with CMC and external partners, develop risk assessments, contribute to regulatory documentation, and communicate strategies across cross-functional teams in a fast-paced, collaborative environment.