Senior Mass Spectrometry Specialist (Permanent) New

POSITION DESCRIPTION:

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.