Toxicologist

About Neuralink:

We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement to the paralyzed, restore sight to the blind, and revolutionize how humans interact with their digital world.

Team Description:

The Biocompatibility team plays a critical role in supporting the manufacture of Neuralink devices by ensuring product safety, quality, and regulatory compliance. We specialize in a range of essential processes, including toxicological risk assessments, batch release testing, chemical characterization, general analytical testing (such as mass spectrometry, chromatography, pH/conductivity, and general chemistry), microbiological testing (bioburden, environmental monitoring, and more), material analysis, clinical chemistry, and in-vitro biocompatibility assays.

Job Description and Responsibilities:

As a Toxicologist, you will lead toxicological risk assessments and biocompatibility evaluations to advance the safety of our brain-computer interface technologies. This role offers the opportunity to own key processes in a collaborative, fast-paced environment focused on innovative medical devices, while ensuring alignment with regulatory standards like ISO 10993 and FDA guidelines.The Toxicologist will:

• Prepare toxicological risk assessment reports, biological safety evaluations, and contribute to FDA and international regulatory submissions
• Own toxicological risk assessment (TRA), including developing and documenting standard operating procedures (SOPs) that outline the TRA process and utilizing risk assessment tools such as the QSAR toolbox, read-across methodologies, and other risk assessment resources
• Conduct hazard identification, literature reviews, and dose-response assessments to support TRA
• Interpret chemical characterization data in accordance with ISO 10993 standards and integrate findings into comprehensive biocompatibility assessments for medical devices
• Collaborate with engineering teams to provide expert consultation on the selection of materials and chemical agents used in manufacturing processes
• Lead the development, validation, and ongoing sustainment of in-vitro biocompatibility assays, ensuring reproducibility, appropriate endpoints, and compliance with international guidance
• Support general laboratory operations, including equipment management, calibration, and routine maintenance tasks to maintain a safe and efficient workspace

Required Qualifications:

• B.S. in toxicology, pharmacology, biochemistry, or a related field
• >1 year of experience in toxicological risk assessment, preferably in the medical device or pharmaceutical industries
• Proficiency in risk assessment methodologies and tools, such as QSAR modeling and read-across
• Excellent analytical, problem-solving, and communication skills, with the ability to collaborate across interdisciplinary teams
• Ability to conduct thorough literature searches

Preferred Qualifications:

• M.S. or PhD in toxicology, pharmacology, biochemistry, or a related field
• Strong knowledge of ISO 10993 standards and experience with chemical characterization and biocompatibility evaluations
• Hands-on experience with in-vitro assay development and cell culture techniques
• >3 years of experience in toxicological risk assessment, preferably in the medical device industry or pharmaceutical industry
• Certification as a Diplomate of the American Board of Toxicology (DABT) or similar professional credential
• Familiarity with FDA and international regulatory submissions