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