LCMS Bioanalytical Method Specialist

3 weeks ago

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

About HAR Labcorp Early Development Laboratories Limited:

As a prominent contract research organization, HAR Labcorp offers extensive drug development services across various sectors. We excel in nonclinical safety evaluation, clinical trial analysis, and management services. Together with our partners, we facilitate the advancement of groundbreaking, life-altering therapies.

Position Overview:

Our major facility is actively seeking a LCMS Method Development Specialist to enhance our Bioanalytical Team.

This role is primarily laboratory-based, focusing on the creation of LCMS bioanalytical methodologies that will subsequently be validated and employed by our operational teams for the analysis of client drug products. We are particularly keen on candidates with expertise in high-resolution mass spectrometry as we broaden our capabilities in this domain.

The ideal candidate will integrate into our innovative team, concentrating on the formulation of regulatory-compliant analytical methods for the quantification and characterization of both small and large biomolecules, including proteins, antibody-drug conjugates (ADCs), and biomarkers, utilizing liquid chromatography-mass spectrometry (LC/MS) and high-resolution mass spectrometry (HRMS). These methods will be transitioned to validation and utilized in support of regulatory submissions.

Key Responsibilities:

  • Design, refine, and prepare LC/MS and HRMS methodologies for regulatory compliance, ensuring they adhere to validation and transfer standards.
  • Conduct method development for the bioanalysis of small molecules.
  • Execute both bottom-up and top-down method development for large molecule bioanalysis: Bottom-Up Method Development: Enzymatic digestion of proteins into peptides followed by LC/MS analysis for the identification, quantification, and characterization of proteins and post-translational modifications. Top-Down Method Development: Direct analysis of intact proteins and protein complexes using LC/MS to enable detailed characterization of protein structure, including proteoforms and complex modifications.
  • Collaborate with validation teams to ensure effective method transfer and implementation.
  • Troubleshoot and maintain LC/MS and HRMS instrumentation to guarantee optimal functionality.
  • Stay informed about advancements in LC/MS and HRMS technologies and bioanalytical practices, applying best practices to enhance laboratory efficiency and capabilities.

Key Qualifications:

  • Over 5 years of practical experience with LC/MS, particularly in developing methods for analyzing large biomolecules such as proteins and ADCs.
  • Proficiency in high-resolution mass spectrometry (HRMS) and its integration with standard LC/MS workflows.
  • Extensive background in both bottom-up and top-down method development for large molecule bioanalysis.
  • Expertise in creating methods that are regulatory-compliant and can be smoothly transitioned to validation.
  • Strong knowledge of regulatory standards and guidelines (e.g., ICH M10) for bioanalytical method validation.
  • Skilled in sample preparation techniques for both small and large molecules, including immunoaffinity capture, solid-phase extraction, and protein precipitation.
  • Proven experience in method development and troubleshooting of LC/MS and HRMS assays for both small and large molecule bioanalysis.
  • Proficient in data analysis software and statistical tools commonly utilized in bioanalysis.
  • Excellent problem-solving abilities, meticulous attention to detail, and capacity to work independently as well as collaboratively.
  • Strong communication skills, capable of effectively conveying complex scientific concepts to both technical and non-technical audiences.
  • Familiarity with biopharmaceutical development processes and regulatory expectations for bioanalysis.
  • Previous experience in a GLP & GCP bioanalysis-compliant environment.

What HAR Labcorp Early Development Laboratories Limited can provide:

  • A thorough training program to enhance your technical and managerial skills.
  • Exceptional career advancement opportunities.
  • The chance to collaborate with a diverse range of clients on various projects.
  • Competitive compensation and a comprehensive benefits package, including health coverage and a contributory pension plan.
  • Relocation assistance if applicable.

HAR Labcorp is committed to being an Equal Opportunity Employer:

As an EOE/AA employer, HAR Labcorp promotes diversity and inclusion within the workforce and does not tolerate any form of harassment or discrimination. Employment decisions are made based on business needs and individual qualifications, without discrimination based on race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all qualified individuals to apply.

For further details on how we collect and manage your personal data, please refer to our privacy policy.

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