Principal I, Microbiology & Toxicology

About the role

Alcon is seeking a Principal I Medical Device Toxicologist to lead biological safety evaluations for medical devices, combination products, and related materials throughout their lifecycle. The role combines toxicology expertise with strategic problem‑solving and cross‑functional leadership.

Key responsibilities

• Develop and execute risk‑based biological evaluation strategies for new and existing products, including manufacturing changes.
• Author and critically review Biological Evaluation Plans and Reports, applying ISO 10993‑1 principles.
• Integrate extractables/leachables data, chemical characterizations, and toxicological hazard information to assess patient risk.
• Lead biocompatibility workstreams, manage project timelines, budgets, and risks.
• Contribute to global regulatory submissions and defend toxicology content with FDA and other authorities.

Required profile

• 5+ years of relevant experience in medical device or pharmaceutical toxicology.
• MS or PhD in Toxicology or a related discipline.
• Experience with regulatory submissions, ISO 10993 standards, and global regulatory expectations.

Required skills

• Application of ISO 10993‑1 and ISO 10993‑17 standards.
• Computational toxicology methods such as read‑across and weight‑of‑evidence assessments.
• Statistical analysis and proficiency with Microsoft Office suite.