Development Scientist

3 weeks ago

Harrogate, North Yorkshire, United Kingdom Laboratory Corporation Full time
About LabCorp Drug Development

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

The Role

Our Harrogate site is seeking a Method Development Specialist to join the LCMS Bioanalysis team. This lab-based position involves performing sample analysis of client's small molecule drug products.

The successful candidate will join our dynamic team and focus on developing regulatory-ready analytical methods 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). These methods will be transferred to validation and used in support of regulatory submissions.

Key Responsibilities
  • Develop, optimize, and prepare LC/MS and HRMS methods for regulatory readiness, ensuring they meet the required standards for validation and transfer.
  • Perform method development for the bioanalysis of small molecules.
  • Perform both bottom-up and top-down method development for the bioanalysis of large molecules:
    • 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 allow for detailed characterization of protein structure, including proteoforms and complex modifications.
  • 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.
Requirements
  • 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.
  • 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.
  • 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.
  • 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 Offers
  • A comprehensive training plan.
  • 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.

Labcorp is proud to be an Equal Opportunity Employer. We strive for diversity and inclusion in the workforce and do not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon 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. For more information about how we collect and store your personal data, please see our Privacy Statement.

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