Team Description:

The Biocompatibility Team is responsible for executing a wide range of assays, performing method validations, finalizing reports, and supporting R&D activities. We are a dedicated group of highly skilled professionals committed to ensuring the accuracy, reliability, and regulatory compliance of test methods used in quality control. With deep expertise in analytical techniques, including chemical characterization, microbiological testing, and biocompatibility evaluations, as well as manufacturing processes such as cleaning, sterilization, and passivation, this team plays a critical role in maintaining the highest standards of product quality and patient safety.

Job Description and Responsibilities:

The Chemist will collaborate with cross-functional teams across Neuralink to analyze the chemical and biological characteristics of manufacturing processes and finished devices. This role involves various levels of product testing during R&D and product release to generate data required for regulatory approvals. The data produced will help confirm patient safety in accordance with applicable global regulations, regulatory guidelines, and voluntary consensus standards.

Daily responsibilities include drafting internal procedures and test protocols, sample preparation, laboratory testing, method development, inventory management, and other general laboratory tasks. The primary goal of the Chemist is to support medical device chemical and biological characterization to ensure patient safety and facilitate regulatory approval. Additional responsibilities include:

• Preparing test samples and controls for analysis
• Performing chromatographic and mass spectrometric analysis using instruments such as LC-MS, GC-MS, and ICP-MS
• Conducting routine and non-routine testing of materials and products to ensure compliance with quality standards and regulatory requirements, including performing calibration checks and maintaining proper documentation
• Delivering test results related to device characteristics to support manufacturing changes and risk assessments
• Preparing laboratory reports that comply with applicable medical device evaluation standards and FDA/ISO guidance documents within a risk-based framework
• Collaborating with cross-functional teams to support multiple projects, ensuring timely completion of laboratory deliverables to meet project timelines
• Analyzing test results to determine whether data meets internal and external requirements; utilizing problem-solving skills and technical expertise to troubleshoot unexpected outcomes
• Participating in continuous improvement initiatives to increase laboratory efficiency, reduce turnaround times, and enhance data quality

Required Qualifications:

• Bachelor of Science in Chemistry, Biochemistry, or a related field
• 1-2 years of experience in an analytical laboratory
• Strong knowledge of basic laboratory operations, including weighing, sample handling, and preparation of volumetric solutions
• Ability to perform routine analytical chemistry calculations (for example, dilutions, concentrations, and result calculations)
• Basic understanding of laboratory safety and proper use of engineering controls (for example, fume hoods and biological safety cabinets)
• Demonstrated ability to develop and optimize analytical methods for efficiency and compliance
• Strong problem-solving mindset
• Excellent written and oral communication skills

Preferred Qualifications:

• Master's degree in Chemistry, Biochemistry, or a related field
• Familiarity with Good Laboratory Practices (GLP) and/or Good Manufacturing Practices (GMP)
• Hands-on experience with LC-MS, GC-MS, and ICP-MS
• Familiarity with chromatography data systems
• Experience with statistical analysis
• Experience troubleshooting analytical instrumentation
• Experience performing bioanalytical procedures and cell-based assays
• Experience with method validation and transfer