Principal Chemist

We anticipate the application window for this opening will close on - 13 Aug 2026 At Mini Med, you can begin a lifelong career of exploration and innovation, while helping make a difference in the lives of people living with diabetes around the globe. You'll lead with purpose, breaking down barriers to innovation for a more connected, compassionate world.

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. The successful candidate will lead the identification and structural elucidation of unknown compounds, degradation products, additives, and trace contaminants using advanced mass spectrometry techniques and non-targeted analytical approaches.

This role requires extensive experience in chromatographic and mass spectral data analysis, including fragmentation interpretation, spectral library searching, and generation of scientifically defensible conclusions to support product development, failure investigations, and global regulatory submissions. Experience with ACD/Labs software for compound identification, structure elucidation, and spectral prediction is highly desirable. The candidate will collaborate cross-functionally with toxicologists, materials scientists, product development teams, and external laboratories to develop analytical strategies, evaluate material safety, and support chemical risk assessments in accordance with ISO 10993 requirements.

Strong technical writing skills and the ability to translate complex analytical findings into clear recommendations and regulatory documentation are essential for success in this role.

Responsibilities may include the following and other duties may be assigned:

• 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.

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.
• 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., Mass Hunter, Xcalibur, UNIFI, Compound Discoverer, MSD Chem Station) is considered an advantage.
• Strong technical writing and data presentation skills, including preparation of technical reports, regulatory documentation, and scientific…