Job Description

Key Responsibilities:

• Analyze and interpret LC-MS data (primarily QTOF) for qualitative and semi-quantitative chemical characterization studies.
• Evaluate mass spectral data using a weight-of-evidence approach, including critical assessment of database matches, fragmentation patterns, isotopic distributions, and chromatographic behavior.
• Collaborate with technical analysts, chemists, and project managers to communicate findings, resolve discrepancies, and meet client expectations.
• Ensure data integrity and compliance with regulatory and accreditation standards (e.g., ISO 10993, ISO 17025, GLP).
• Document findings in established systems, supporting traceability and reporting.
• Contribute to method development and optimization by providing feedback on spectral data trends and anomalies.
• Support improvement of SOPs, templates, and data analysis workflows.
• Identify and troubleshoot potential prep or instrument-related issues affecting data integrity.
• Participate in continuous improvement initiatives and inter-laboratory collaborations.
• Other duties as assigned by management.

Additional Knowledge/ Qualifications:

• BS/B.Sc in Chemistry or a related field with 5+ years relevant experience, or MSc./PhD with 2+ years of relevant experience.
• Proficient in interpreting LC-MS/MS and chromatographic data.
• Experience working in a regulated environment (ISO 17025, ISO 10993, GLP/GMP).
• Familiarity with Microsoft Excel for data documentation and review.

Preferred Candidate:

• Background in organic chemistry, including functional group recognition and mass fragmentation behavior.
• Experience with extractables & leachables, particularly in a medical device or pharmaceutical context.
• Understanding of instrumental analysis workflows and solution preparation.
• Awareness of how sample prep or instrument anomalies affect data outcomes.
• Familiarity with relevant databases and software for compound identification.

Skills Required