Toxicologist

Excelya; France; Hybride; EUR 70 000 - 100 000; Plein temps

Résumé du poste

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).

Responsabilités

• 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.

Connaissances

toxicology

genotoxicity strategies

HBEL/OEL PDE

impurity assessment

ICH guidelines knowledge

in silico toxicology tools

Formation

Master's or PhD in Toxicology/Biology/Pharmacology

Outils

Genotoxicity testing

In silico toxicology tools

Description du poste

Join Excelya, where Audacity, Care and Energy define who we are and how we work. We believe in creating ambitious solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role offers an exciting opportunity to join a dynamic and ambitious team supporting drug development programs from preclinical stages through market authorization. You will provide toxicology expertise related to impurity assessment, genotoxicity strategies, and health-based exposure limits within a highly collaborative and regulated environment.

Key Responsabilities :

• 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 Permitted Daily Exposures (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.

• 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).

Why join us?

At Excelya, we combine a passion for science with the enthusiasm of teamwork to redefine excellence in healthcare.

Here’s what makes us unique:

We are a young and ambitious healthcare company, bringing together 900 Excelyates, driven by the goal of becoming the leading mid-sized CRO in Europe, while offering the best employee experience.

Our \"one-stop provider\" service model—combining full-service, functional service provider, and consulting—allows you to grow through diverse and stimulating projects. By collaborating with leading experts, you will contribute to the development of scientific, operational, and human knowledge, all in service of improving the patient journey.

Excelling with kindness means evolving in an environment that values your natural talents, encourages boldness, pushes boundaries, and cultivates your potential, so that you can fully contribute to our shared mission.