LCMS Method Development Specialist

3 weeks ago

Harrogate, North Yorkshire, United Kingdom HAR Labcorp Early Development Laboratories Limited Full time

About LabCorp Drug Development:

We are a leading contract research organization providing comprehensive drug development solutions for various industries. Our nonclinical safety assessment, clinical trial testing, and clinical trial management services support the development of innovative life-changing treatments.

The Role:

We are recruiting a Method Development Specialist to join the LCMS Bioanalysis team at our Harrogate site. This lab-based position involves developing LCMS bioanalytical methods that will be validated and utilized by the operations team for client small molecule drug product analysis.

The successful candidate will join our dynamic team and focus on regulatory-ready analytical method development for the quantification and characterization of small and large molecules, including proteins, antibody-drug conjugates (ADCs), and biomarkers, using liquid chromatography-mass spectrometry (LC/MS) and high-resolution mass spectrometry (HRMS).

Key Responsibilities:

  • Develop, optimize, and prepare LC/MS and HRMS methods for regulatory readiness, ensuring they meet required standards for validation and transfer.
  • Perform method development for the bioanalysis of small molecules.
  • Perform bottom-up and top-down method development for the bioanalysis of large molecules.
  • Collaborate with validation teams to ensure smooth method transfer and implementation.
  • Troubleshoot and maintain LC/MS and HRMS instrumentation to ensure optimal performance.
  • Stay current with advancements in LC/MS and HRMS technology and bioanalytical techniques, applying best practices to enhance lab efficiency and capabilities.

Key Qualifications:

  • 5+ years of hands-on experience with LC/MS, specifically in the development of methods for the analysis of large molecules such as proteins and ADCs.
  • Expertise in high-resolution mass spectrometry (HRMS) and its application alongside standard LC/MS workflows.
  • Extensive experience in bottom-up and top-down method development for large molecule bioanalysis.
  • Proficiency in developing methods that are regulatory-ready and can be seamlessly transferred to validation.
  • Strong understanding of regulatory requirements and guidelines (e.g., ICH M10) for bioanalytical method validation.
  • Proficiency in sample preparation techniques for both small and large molecules.
  • Proven track record in method development and troubleshooting of LC/MS and HRMS assays for both small and large molecule bioanalysis.
  • Proficiency in data analysis software and statistical tools commonly used in bioanalysis.
  • Excellent problem-solving skills, attention to detail, and ability to work independently as well as part of a team.
  • Strong communication skills, with the ability to effectively convey complex scientific information to both technical and non-technical audiences.
  • Knowledge of biopharmaceutical development processes and regulatory expectations for bioanalysis.
  • Previous experience in a GLP & GCP bioanalysis-compliant environment.

What LabCorp Drug Development can offer you:

  • A comprehensive training plan with the ability to develop your technical and managerial skills.
  • Unsurpassed career development opportunities.
  • Ability to work with a variety of different clients on wide-ranging projects.
  • Competitive salaries and a comprehensive benefits package, including health cover and contributory pension.
  • Relocation assistance if applicable.

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