Biocompatibility Scientist

Neuralink•Austin, TX

59d•$71,000 - $119,000

About The Position

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. 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. As a Biocompatibility Scientist, you will drive the development of in-vitro biocompatibility methods 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 OECD guidance.

Requirements

B.S. in molecular biology, toxicology, pharmacology, biochemistry, or a related field
Strong background in cell biology, molecular biology, and/or toxicology
>1 year of experience with in-vitro method development (including academic or research experience)
Proficiency with confocal microscopy
Excellent analytical, problem-solving, and communication skills, with the ability to collaborate across interdisciplinary teams
Ability to conduct thorough literature searches

Nice To Haves

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
Familiarity with in-vivo models
>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

Responsibilities

Assist with the setup of necessary laboratory equipment, including calibration and qualification, if needed
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
Collaborate with engineering teams to provide expert consultation on the selection of materials and chemical agents used in manufacturing processes
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

Benefits

An opportunity to change the world and work with some of the smartest and most talented experts from different fields
Growth potential; we rapidly advance team members who have an outsized impact
Excellent medical, dental, and vision insurance through a PPO plan
Paid holidays
Commuter benefits
Meals provided
Equity (RSUs) Temporary Employees & Interns excluded
401(k) plan Interns initially excluded until they work 1,000 hours
Parental leave Temporary Employees & Interns excluded
Flexible time off Temporary Employees & Interns excluded