Senior Mass Spectrometry Specialist (Permanent)

POSITION DESCRIPTION:

The Senior Mass Spectrometry Analyst will be responsible for taking oversight of all mass spectrometry activities in the R&D group, and providing technical support for these activities, as well as developing mass spectrometry methods to support method introduction for new products. In addition, the successful candidate will provide technical support for all aspects of mass spectrometry analysis including method transfer, method qualification and method troubleshooting pertaining to the manufacture of small molecule APIs, intermediates RSMs and peptides. The successful candidate will also provide support in the day-to-day running and maintenance of mass spectrometry instruments in the AR&D laboratories. The successful candidate will need to collaborate closely with other functions, including Process R&D, Technology transfer, Quality (QA/QC), SHE and external stakeholders/customers working towards the flawless, compliant and right first-time manufacture of existing and new products. In addition, the successful candidate will provide mentorship, where applicable, to more junior analytical staff.

KEYRESPONSBILITIES:

• Lead the development, optimization, and validation of GC-MS, LC-MS, LC-MS/MS and LC-HRMS methods for small molecule and peptide analysis using Waters (e.g., QDa, Xevo G2S) and Agilent (e.g., 5977B, Ultivo) instrumentation.
• Develop, optimize, and validate robust LC-MS and LC-MS/MS methods for:
  • Characterization and quantification of APIs, RSMs, and peptides
  • Detection of impurities and degradation products
  • Structural elucidation and mass confirmation
• Support characterization of small molecules, peptides, and complex formulations.
• Support peptide characterization including:
  • Sequence confirmation
  • Purity and identity testing
  • Post-translational modification (PTM) profiling
• Perform structural elucidation, impurity profiling, and impurity identification using high-resolution MS and tandem MS techniques.
• Perform instrument troubleshooting, calibration, and maintenance (e.g., QQQ, QTOF, Orbitrap, or equivalent platforms from Waters, or Agilent).
• Interpret complex MS data and collaborate with cross-functional teams to ensure data-driven decisions.
• Prepare detailed documentation: protocols, SOPs, validation reports, analytical method transfer documents, and technical reports for customer submissions.
• Collaborate with cross-functional teams including Process R&D, Quality (QA/QC), SHE and external stakeholders/customers.
• Ensure compliance with GMP and regulatory guidelines (FDA, EMA, ICH).
• Maintain and optimize Waters and Agilent MS systems and associated software (e.g. UNIFI, OpenLab, Empower, MassHunter etc.).
• Troubleshoot instrumentation and ensure optimal performance.
• Act as a subject matter expert (SME) in LC-MS for internal and external stakeholders.
• Evaluate and implement new technologies and workflows to enhance analytical capabilities.
• Ensure all instrumentation used is within calibration and is correctly maintained.

KEY SKILLS AND QUALIFICATIONS:

• MSc/PhD in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related field.
• Minimum 5 years of hands-on experience in mass spectrometry for small molecule analysis in a CDMO, pharmaceutical or biotech setting.
• Proven experience working with small molecules, peptides, and complex raw materials.
• Familiarity with regulatory guidelines (ICH, FDA, EMA) related to API and peptide development.
• Extensive hands-on experience with MS systems in a pharmaceutical R&D or QC setting, ideally with experience with both Waters and Agilent GC-MS, LC-MS, LC-MS/MS and LC-HRMS platforms and software tools.
• Familiarity with QbD principles and statistical tools (e.g., JMP, Minitab).
• Knowledge of FDA and European GMPs requirements, particularly pertaining to laboratory operations MS workflows using Waters and Agilent systems.