Senior Toxicologist

Baxter's Pharmaceutical Segment is seeking an experienced senior toxicologist to support the development and registration of pharmaceuticals. This individual will be responsible for authoring toxicological risk assessments, evaluating container closure system extractables and leachables, and supporting the development of responses to regulatory deficiencies.

• Author toxicological risk assessments of API and drug formulation impurities/degradants.
• Evaluate container closure system extractables and leachables.
• Support the development of responses to regulatory deficiencies.
• Author and review preclinical regulatory submission content.
• Aid in study design and monitor GLP safety studies.
• Provide support to manufacturing in change control initiatives and safety evaluation.

• MS degree and +15 years of experience or PhD with +10 years of experience.
• Working knowledge of toxicology and preclinical regulatory requirements.
• Ability to use in silico tools to support safety assessments.
• Demonstrated technical writing ability and oral presentation skills.
• Critical thinking skills and ability to adapt and learn new skills.

Baxter offers a dynamic and matrixed multidisciplinary team environment that is responsible for ensuring the safety of both drugs and drug-device combinations. This is an opportunity to become part of a highly collaborative team that is committed to improving outcomes for millions of patients worldwide.