We are seeking a motivated lab analyst to join our pharmaceutical analytical laboratory. The successful candidate will contribute to the identification and investigation of visible and subvisible particles encountered during stability studies, quality investigations, and development projects. The role also includes involvement in the development, validation, and application of LC-MS and GC-MS analytical methods. This position offers a unique opportunity to build expertise at the intersection of material characterization, mass spectrometry, and pharmaceutical stability testing. Main responsibilities include:
Particle Identification and Material Characterization
- Conduct investigations of particles, fibers, polymeric materials, and other potential contaminants.
- Utilize structural and physicochemical characterization techniques such as optical microscopy, FTIR, Raman spectroscopy, SEM/EDS, or equivalent techniques.
- Interpret analytical data to determine the likely origin and nature of unknown particles.
- Prepare technical reports and communicate findings to project, quality, and cross-functional teams.
LC-MS and GC-MS Method Development and Application
- Develop, optimize, and execute analytical methods using liquid chromatography-mass spectrometry (LC-MS) and gas chromatography-mass spectrometry (GC-MS).
- Support structural elucidation and identification of extractables and leachables (E&L), degradation products, and unknown compounds.
- Perform routine analyses as well as complex investigations requiring interpretation of mass spectral data.
- Contribute to instrument maintenance, troubleshooting, and qualification activities.
Analytical Method Validation
- Participate in the planning and execution of analytical method validation studies.
- Assess method performance characteristics including specificity, accuracy, precision, linearity, robustness, solution stability, and range.
- Previous experience with analytical method validation is considered an advantage but is not required.
Stability Testing
- Prepare and analyse samples generated from stability study programs.
- Review and interpret analytical results.
- Support investigations related to atypical, out-of-trend, or unexpected stability results.