Principal Chemist

About the role

We are seeking a highly motivated analytical chemist with strong expertise in LC-MS and GC-MS data interpretation to support chemical characterization, extractables and leachables (E&L) studies, and material investigations for medical device products.

Responsibilities

• Conduct exploratory research to generate new scientific knowledge and develop innovative solutions supporting product development and material characterization objectives.
• Conceive, organize, promote, and execute research strategies that enhance the application of chemistry and analytical sciences in product discovery and development.
• Develop research proposals and experimental plans to provide technically and economically sound approaches for evaluating new or improved products, materials, synthetic methods, processes, and analytical methodologies.
• Design, develop, optimize, and apply advanced analytical methods, particularly LC-MS and GC-MS, to support extractables and leachables studies, chemical characterization, and identification of unknown compounds.
• Independently interpret complex analytical data, including mass spectral fragmentation patterns and chromatographic profiles, and communicate findings with scientifically justified conclusions and recommendations.
• Support chemical characterization and toxicological risk assessments in accordance with applicable regulatory expectations and international standards, including ISO 10993 requirements.
• Collaborate with cross-functional teams, external laboratories, and suppliers to resolve technical issues related to materials, manufacturing processes, and product performance.
• Prepare and review technical reports, protocols, regulatory submissions, and scientific publications to ensure data integrity and compliance with quality and regulatory requirements.
• Recommend utilization of research results, modifications to project scope, strategic direction changes, or project termination based on scientific findings and business needs.

Requirements

• Requires a Bachelors degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.
• Strong knowledge and hands-on experience in analytical chemistry techniques, particularly LC-MS and GC-MS for extractables and leachables (E&L), chemical characterization, and unknown identification studies.
• Demonstrated expertise in LC-MS and GC-MS data processing, interpretation, and structural elucidation of unknown compounds, including identification of degradation products, additives, oligomers, and trace contaminants.
• Experience with non-targeted screening, spectral library searching, fragmentation pathway interpretation, and generation of scientifically defensible conclusions to support regulatory submissions and risk assessments.
• A good understanding of ISO 10993-18, ISO 10993-17, and chemical risk assessment principles is highly desirable.
• Experience using ACD/Labs software for chromatographic and mass spectral data analysis, structure elucidation, spectral prediction, and compound identification is preferred.
• Experience with other analytical software platforms (e.g., MassHunter, Xcalibur, UNIFI, Compound Discoverer, MSD ChemStation) is considered an advantage.
• Strong technical writing and data presentation skills, including preparation of technical reports, regulatory documentation, and scientific presentations.
• Demonstrated ability to independently analyze complex analytical datasets and provide technical recommendations to support material characterization, failure investigations, and product development activities.

Qualifications

• Preferred qualifications include experience with ISO 10993-18, ISO 10993-17, and chemical risk assessment principles.
• Experience using ACD/Labs software for chromatographic and mass spectral data analysis, structure elucidation, spectral prediction, and compound identification is preferred.
• Experience with other analytical software platforms (e.g., MassHunter, Xcalibur, UNIFI, Compound Discoverer, MSD ChemStation) is considered an advantage.

Skills

• Strong technical writing and data presentation skills, including preparation of technical reports, regulatory documentation, and scientific presentations.
• Demonstrated ability to independently analyze complex analytical datasets and provide technical recommendations to support material characterization, failure investigations, and product development activities.

Benefits & Compensation

MiniMed offers a competitive salary and flexible benefits package. Salary ranges for U.S. (excl. PR) locations (USD): $109,000.00 - $185,000.00 For roles located in California, Seattle WA, Washington DC, Boston MA, and New York City, the salary range is $121,000.00 - $205,000.00 USD. Actual compensation may vary based on factors including experience, education, certifications, skills, market conditions, internal equity, and geographic location.