Toxicology Scientist - Impurity & Genotoxicity Expert

Excelya; France; Hybrid; EUR 70,000 - 100,000; Full time

Job summary

Excelya is seeking a talented toxicology expert to join our drug development support team. You will provide toxicology input on impurities, extractables and leachables, and genotoxic impurities within a regulated, collaborative environment.

The role emphasizes ICH Q3A/B/C and ICH M7 familiarity, PDE/HBEL/OEL derivation, and communication with CMC and cross-functional partners to shape safety strategies and regulatory justifications.

Qualifications

• Master's degree or PhD in Toxicology, Biology, Pharmacology, or a related scientific discipline.
• Experience in toxicology and supporting pharmaceutical development programs is highly desirable.
• Strong knowledge of ICH Q3A/B/C and ICH M7 guidelines.
• Proven experience with genotoxicity assessment strategies.
• Hands-on experience with genotoxicity testing and in silico toxicology tools.
• Experience in health-based exposure limit derivation (PDE, HBEL, OEL).
• Understanding of impurity qualification and risk assessment methodologies.
• Fluent English (written and spoken).

Responsibilities

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

Skills

toxicology

genotoxicity strategies

HBEL/OEL PDE

impurity assessment

ICH guidelines knowledge

in silico toxicology tools

Education

Master's or PhD in Toxicology/Biology/Pharmacology

Tools

Genotoxicity testing

In silico toxicology tools

Job description

Excelya is seeking a talented toxicology expert to join our drug development support team. You will provide toxicology input on impurities, extractables and leachables, and genotoxic impurities within a regulated, collaborative environment.

The role emphasizes ICH Q3A/B/C and ICH M7 familiarity, PDE/HBEL/OEL derivation, and communication with CMC and cross-functional partners to shape safety strategies and regulatory justifications.