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Analytical Method Developer (LC-MS/GC-MS – Nitrosamine Impurities)

SCIOM Limited
Welwyn Garden City
1 week ago
Applications closed

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Job Summary:

We are looking for a highly motivated and skilledAnalytical Method Development Analystwith hands-on experience inAgilent LC-MS and GC-MS systems, focusing on thedevelopment and validation of methods for Nitrosamine impuritiesin pharmaceutical substances and products. The candidate should have a strong understanding of regulatory expectations, impurity profiling, and analytical troubleshooting in a GMP-compliant environment.


Key Responsibilities:

  • Develop, optimize, and validate analytical methods for the detection and quantification of Nitrosamine impurities using Agilent LC-MS/MS and Agilent GC-MS/MS systems (Triple Quadrupole or QTOF).
  • Operate and maintain Agilent instrumentation, including system calibration, maintenance, and basic troubleshooting.
  • Use Agilent MassHunter software for data acquisition, processing, and reporting of LC-MS and GC-MS results.
  • Conduct method validation as per ICH Q2 (R1) guidelines, and prepare protocols and reports accordingly.
  • Perform risk-based impurity profiling for Nitrosamines based on synthetic pathway, excipient reactivity, and formulation interactions.
  • Execute forced degradation studies and assess potential nitrosamine formation under stress conditions.
  • Prepare and maintain technical documentation such as method development reports, SOPs, validation protocols/reports, and regulatory submission content.
  • Ensure compliance with GMP, GLP, and data integrity standards (ALCOA+) throughout all analytical activities.
  • Support regulatory audits and inspections by providing method details and data summaries related to nitrosamine testing.
  • Collaborate with cross-functional teams including QA, Regulatory Affairs, and Formulation Development.


Qualifications:

  • M.Sc. / B.Pharm / M.Pharm in Analytical Chemistry, Pharmaceutical Chemistry, or related discipline.
  • 2–5 years of hands-on experience in method development using Agilent LC-MS and GC-MS, with a focus on Nitrosamine impurities.
  • Proficiency in Agilent MassHunter software (Qual, Quant, Optimizer) and OpenLab.
  • Sound knowledge of Nitrosamine risk assessment, ICH M7, and current regulatory guidance.


Preferred Skills:

  • Experience with software likeMassHunterandOpenLab.
  • Familiarity withstructural elucidationusing MS/MS fragmentation.
  • Knowledge ofICH M7 (R1),genotoxic impurities (GTIs), andcarcinogenic risk assessment.
  • Experience with sample preparation techniques (e.g., derivatization, headspace analysis).
  • Familiarity with LOD/LOQ requirements for Nitrosamines (ppb level sensitivity).
  • Understanding of mass fragmentation patterns, ion source tuning, and matrix effect management.


Soft Skills:

  • Strong analytical and problem-solving mindset.
  • Good communication and report-writing skills.
  • Ability to work independently and manage priorities effectively.
  • Team player with a proactive approach to learning and continuous improvement.


Experience Level:Mid-Level

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