Research Scientist I

Junior Toxicologist

We are seeking a junior toxicologist to join our team on a contract basis. The contractor will provide specialized expertise in toxicology to support short-term projects, ensuring compliance with regulatory standards and delivering high-quality risk assessments. This role requires strong technical knowledge, independence, and collaboration with internal teams and external partners.

Key responsibilities include:

• Conduct toxicological risk assessments for chemicals, impurities, excipients, and leachables/extractables in accordance with ISO 10993 and ICH/FDA guidelines.
• Collaborate with cross-functional teams (MTO, CMC) and external CROs to support nonclinical safety evaluations.
• Maintain accurate documentation and prepare reports for regulatory submissions.
• Advise on toxicology-related issues during product development and lifecycle management.

Preferred skills include:

• Experience with extractables/leachables studies and biological safety risk assessments.
• Strong collaboration skills for working with internal stakeholders and external vendors.